MINUTES OF 239th MEETING OF DRUGS REGISTRATION BOARD HELD

ON 12th September, 2013

239th meeting of the Drugs Registration Board was held on 12th September,
2013 in the Committee Room, Minitrsy of National Health Regulation Service &
Coordination Division, Local Government Building, G-5, Islamabad. The meeting was
chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division. The meeting started with the recitation of Holy Verses. The
meeting was attended by the following:-
1. Prof.Dr.Rafi-uz-Zaman Saeed-ul-Haq. Dean, Member
University of Lahore, Islamabad
2. Lt General (R) Karamat Ahmed Karamat. Member

3. Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Member

Basic Sciences Division, Foundation Medical
University, Rawalpindi.

4. Mr. A.Q. Javed Iqbal, Chief Pharmacist, PIMS, Member

Islamabad.
awalpindi.
5. Dr. Muhammad Arshad, President, Pakistan Veterinary Member
Medical Council

6. Dr. Muhammad Khalid Khan Member

Director Drugs Testing Laboratory Government of
Khyber Pakhtoonkhwa, Peshawar.

7. Muhammad Jamil Anwar Member

Director Drugs Testing Laboratory Government of
Punjab, Lahore.

8. Dr.Amanullah Khan Member

Director Drugs Testing Laboratory Government of
Baluchistan, Quetta
9. Sheikh Muhammad Idress Member
Director Drugs Testing Laboratory Government of
Sind, Karachi
10. Dr.Noor Muhammad Shah Member
Director Medical Devices and Medicated Cosmetics,
DRAP
 11. Abdul Samad Khan representing Director, Biological Member
Drug, DRAP

12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member

Mr.Akhter Abbas Khan (DDG R.II), Mr.Muhammad Arif (DDC R.I), Mr. Babar
Khan (DDC R.III), Dr. Tariq Siddique (DDC R.IV), Ms. Sara Mehreen (ADC R.I) and
Mr. Atiq-ul-Bari (ADC R.V) assisted Secretary of the Board with agenda.
Dr. Kaiser Waheed & Mr. Hammayun Kabir, Dr.Farid Khan and Dr.M.Qasim
Awan attended the meeting as observer on behalf of PPMA, Pharma Beauru and PVPMA
respectively.

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Item No I: Confirmation of minutes 238th meeting Registration Board.
238th meeting of Registration Board was held on 5th-6th August, 2013 and minutes
were accordingly circulated to all members through e-mail. Only 3 members confirmed
the minutes while observations of Dr. Khalid Khan, Director, DTL, Peshawar are as
follows:
The minutes of 238th RB meeting held on 5-6 Aug. 2013 are approved subject to
partial modifications i.e.
1. In Agenda item 2. Extension in contract manufacturing cases i.e. line
extension/general products/ associated company/ sister concern cases were rejected
rather than deferred.
2. Panel inspection should be conducted by the board members to the premises and
manufacturing facilities of contract givers.
3. Agenda Item delegation of Board power to Chairman, the powers mentioned in serial
v, xii, xv, xvi, xvii, xviii,, and xix should be remained with Board rather delegated to Chairman.
v. Increase/ decrease in shelf life of finished drug.
xii. Renewal of registered drugs.
xv. Change in the packing design/packaging components/ change in label, carton/ change in
shape, colour of Capsule, Tablets and shape of blister/ aluminum foil.
xvi. Change of brand names of registered drugs.
xvii. Change of formulation of already registered drug / grant of registration for
improving Safety, efficacy & quality as per recommendations of WHO / International
Agencies.
xviii. Transfer of registration from one manufacturer/importer to another
manufacture/importer.
xix. Constitution of panel of experts for inspections

4. For medical devices specifications and testing methods. a committee should be

constituted to formulate specifications and testing method procedures according to our
country need in best interest of public at large.
Decision: The Board discussed above mentioned observations of the member
and after detailed discussion decided as follows:
Cases which were not covered in Contract Manufacturing Policy were
deferred, as said policy is under consideration by the Policy Board.

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Panel of inspectors would inspect the manufacturing premesis for grant of
new contract manufacturing permissions, if required by the Board.
Chairman, Registration Board would continue to decide cases mentioned at
point 3. However, all cases which require evaluation of technical data will be
referred to panel of experts including atleast one member of Registration
Board. The Chairman, Registration Board will decide the case keeping in
view recommendation of experts. However, Dr.Khalid Khan maintained his
view point.
Dr.Noor Muhammad Shah, Director MD & MC apprised the Board that
draft Medical Devices Rules, 2013 have already been sent to provincial
governments and also posted / uploaded on DRAP’s website for comments.
He also requested all members of the Board to give inputs on draft
regulations at the earliest.

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 Item No II: Grant of Registration (Local manufacturing).
Applications for registration (July-September, 2010 & fast track) were forwarded to
officers of DRAP. As per review, following applications were found complete.
Registration-I.
Fast track applications for registration (Locally manufactured drugs me-too)
S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision
Applicant Size Life
1. M/s. Baariq Furosebar Water Soluble Powder Decontrolled 02 Approved
Pharmaceuticals, Each 1000gm contains:- 100gm years
Raiwind Road, Furosemide…………….20gm 250gm
Lahore. Potassium Chloride……. 4gm 500gm
Calcium Carbonate…….45gm 1000gm
Magnesium Sulphate…..1gm 2500gm
(Diuretic, Electrolytes).

2. M/s. Baariq Electrobar-C Water Soluble Decontrolled 02 Deferred for PSI

Pharmaceuticals, Powder 100gm years by panel
Raiwind Road, Each gm contains:- 250gm comprising of
Lahore. Aspirin………………..200mg 500gm Area FID and
Vitamin C…………….600mg 1000gm Director DTL,
Sodium Chloride………35mg 2500gm Lahore.
Sodium Citrate………….7mg
(Vitamin, Electrolytes, NSAID).

3. M/s. Baariq Colibar Oral Liquid Decontrolled 02 Approved

Pharmaceuticals, Each 1000ml contains:- 100ml years
Raiwind Road, Colistine 500ml
Lahore. Sulphate……..2,000,000,000 IU 1000ml
(Antibiotic).
4. M/s. Elegance Flurotin Liquid Decontrolled 02 Approved
Pharmaceuticals, Each ml contains 10ml years
Chak Belli, Pandori Florfenicol ….200mg 20ml
Road, Rawalpindi. (Anti-bacterial) 50ml
100ml
150 ml
200ml
250ml
500ml
1Lit

5
5. M/s. Elegance Ecotin-M Powder Decontrolled 02 Approved
Pharmaceuticals, Each 100g contain 100gm years
Chak Belli, Pandori Enrofloxacin HCl……10 % 250gm
Road, Rawalpindi. Colistin Sulphate……..3 % 500gm
Amantadine HCl……..4 % 1Kg
(Anti-Biotic) 5Kg
10Kg
25Kg
6. M/s. Elegance Poly Quin Liquid Decontrolled 02 Approved
Pharmaceuticals, Each 100ml contains 10ml years
Chak Belli, Pandori Enrofloxacin………10 g 20ml
Road, Rawalpindi. Colistin Sulphate….48 MIU 50ml
(Anti-Biotic) 100ml
150 ml
200ml
250ml
500ml
1Lit
7. M/s. D-Maarson Bella Flush Powder Decontrolled 02 Approved
Pharmaceuticals, Each 100g contains:- 100g years
Rawat, Islamabad. Furosemide………………2gm 250g
Belladonna Extract……..0.2gm 500g
(Diuretic, Anti-spasmodic). 1Kg
5Kg
10Kg

8. M/s. Nawal BELLA RAFT Powder Decontrolled 02 Approved

Pharmaceuticals, Each 100g contains:- 100g years
Small Industrial Furosemide…………….2gm 250g
Estate Taxila. Belladonna Extract…..0.2gm 500g
(Diuretic, Anti-spasmodic). 1Kg
5Kg
10Kg

9. M/s. Leads Virox TD Powder Decontrolled 02 Approved

Pharma (Pvt) Ltd., Each Kg contains:- 100gm years
Islamabad. Doxycycline HCI………200gm 250gm
Tylosin Tartrate………..100gm 500gm
Amantadine HCI…………40gm 1Kg
Colistin Sulphate……...500MIU 5Kg
Bromhexine HCL…………5gm 25Kg
(Antibiotic).
10. M/s. Leads Amandx Powder Decontrolled 02 Approved
Pharma (Pvt) Ltd., Each 1000gm contains:- 100gm years
Islamabad. Doxycycline HCI…..….20% 250gm
Tylosin Tartrate ……....10% 500gm
Amantadine HCI……...4.5% 1Kg
(Antibiotic). 5Kg
25Kg
11. M/s. Decent Nortrim-S Oral Liquid Decontrolled 02 Approved

6
 Pharma, Rawat, Each ml contains:- 30ml years
Islamabad. Norfloxacin ……………….10% 50ml
Sulphamethoxypyridazine...15% 100ml
Trimethoprim……………..03% 500ml
(Antibacterial). 1 Liter
2.5 Liter
5 Liter
10 Liter

LOCALLY MANUFACTURED VETERINARY DRUGS FOR THE MONTH OF

NOVEMBER & DECEMBER, 2010.

Registration Board thoroughly discussed the following cases and decided the cases as
mentioned against each.

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision

Applicant Size Life
1. M/s. Inshal Nilza Shell Super Suspension Decontrolled 02 Approved
Pharmaceutical Each 100ml contains:- 100ml years
Industries, Rawat, Oxyclozanide…………….3.0% 150ml
Islamabad. Levamisole Hcl…………..1.5% 250ml
Cobalt Chloride (6H20).0.075% 450ml
Sodium Selenite ……...0.035% 500ml
(Anthalmintic). 1000ml
2.5 Liter

2. M/s. Inshal Clobenda Shell Suspension Decontrolled 02 Approved

Pharmaceutical Each ml of suspension 30ml years
Industries, Rawat, Albendazole……….2.5% 50ml
Islamabad. Closantel…………..0.5% 100ml
(Anthalmintic). 250ml
450ml
500ml
1000ml
2.5 Liter

3. M/s. Inshal Oxfashell Suspension Decontrolled 02 Approved

Pharmaceutical Each 100ml contains:- 30ml years
Industries, Rawat, Oxfendazole………2.265% 50ml
Islamabad. (Anthalmintic). 100ml
250ml
450ml
500ml
1000ml
2.5 Liter

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4. M/s. Inshal Levashell 1.5 Suspension Decontrolled 02 Approved
Pharmaceutical Each 100ml contains:- 50ml years
Industries, Rawat, Levamisole HCI…1.5% 100ml
Islamabad. (Anthalmintic). 150ml
250ml
450ml
500ml
1000ml
2.5 Liter

5. M/s. Inshal Tol Shell Liquid Decontrolled 02 Approved

Pharmaceutical Each ml contains:- 30ml years
Industries, Rawat, Doxycycline HCI……..200mg 50ml
Islamabad. Tylosin Tartrate……….100mg 100ml
Colistin Sulphate….450000 IU 250ml
Bromhexine HCI………4mg 500ml
(Antibacterial, Anti-Viral). 1 Liter
5 Liter
10 Liter
25 Liter

6. M/s. Inshal Mentho Flush Oral Liquid Decontrolled 02 Approved

Pharmaceutical Each 100ml contains:- 30ml years
Industries, Rawat, Sorbitol……………….140mg 50ml
Islamabad. 1,2Propane Diol………60mg 100ml
Magnesium Sulphate 250ml
(6H20)………………..40mg 500ml
Potassium Chloride……20g 1 Liter
Sodium Propionate……3g 5 Liter
(Anti fungal, Antimicrobial). 10 Liter

7. M/s. Inshal Albashell 10 Suspension Decontrolled 02 Deferred for

Pharmaceutical Each 100ml contains:- 30ml years application on
Industries, Rawat, Albendazole USP………..10% 50ml Form 5 D
Islamabad. Cobalt Chloride 100ml along with
(6H20)………………….0.05% 250ml revised Fee
Sodium Selenite………..0.07% 450ml and expert
(Anthalmintic). 500ml views of
1000ml following;
2.5 Liter a. Dr. M
Ashraf,
UVAS
b. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
8. M/s. Inshal Trizo Shell Liquid Decontrolled 02 Deferred for

8
 Pharmaceutical Each 100ml contains:- 50ml years confirmation
Industries, Rawat, Trimethoprim……………..8.0g 100ml of use as
Islamabad. Sulfadiazine Na Sodium….40g 200ml bronchodilator
(Antibacterial, Coccidial, 250ml
Bronchodilator). 500ml
1 Liter
2.5 Liter
25 Liter
9. M/s. Inshal Immunufur E Liquid Decontrolled 02 Deferred for
Pharmaceutical Each 1000ml contains:- 100ml years application on
Industries, Rawat, Sodium Selenite…….150mg 250ml Form 5 D
Islamabad. Vitamin E………..…10,000mg 500ml along with
Choline……………..50,000mg 1 Liter revised Fee
Vitamin C………….35,000mg 5 Liter and expert
Zinc sulphate….…..…4500mg 10 Liter views of
Biotin……………..…100mg 25 Liter following;
Sorbitol………….….50,000mg c. Dr. M
(Immune boster, Multi Vitamin). Ashraf,
UVAS
d. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
10. M/s. Inshal Silymar 2% Liquid Decontrolled 02 Deferred for
Pharmaceutical Each ml contains:- 100ml years application on
Industries, Rawat, Silymarin……….20mg 150ml Form 5 D
Islamabad. Sorbitol………….50mg 250ml along with
(Hepatoprotective). 500ml revised Fee
1 Liter and expert
2.5 Liter views of
following;
e. Dr. M
Ashraf,
UVAS
f. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
11. M/s. Inshal Cyper Shell Liquid Decontrolled 02 Approved
Pharmaceutical Each 100ml contains:- 50ml years
Industries, Rawat, Enrofloxacin………...10g 100ml
Islamabad. Colistin Sulphate……50MIU 150ml
(Antibiotic). 250ml
500ml
1 Liter

9
 2.5 Liter
12. M/s. Inshal Sulfadine Liquid Decontrolled 02 Approved
Pharmaceutical Each 100ml contains:- 50ml years
Industries, Rawat, Enrofloxacin…………...10g 100ml
Islamabad. Colistin Sulphate………3.5g 150ml
Amantadine HCI……….4.0g 250ml
(Antibiotic). 500ml
1 Liter
2 Liter
2.5 Liter

13. M/s. Inshal Bromo Shell Liquid Decontrolled 02 Approved

Pharmaceutical Each 100ml contains:- 100ml years
Industries, Rawat, Bromhexine HCI……..05g 500ml
Islamabad. (Bronchodilator). 1 Liter

14. M/s. Inshal Asper Shell Water Soluble Powder Decontrolled 02 Deferred, for
Pharmaceutical Each 1000g contains:- 30g years PSI by panel
Industries, Rawat, Vitamin C……………..…200g 50g comprising of
Islamabad. Acetyl Salicylic Acid…….67g 100g Area FID and
(NSAIDS + Supplement). 250g A.Q.Javed
500g Iqbal Member
1 Kg RB.
5 Kg
10Kg
15. M/s. Inshal Amento Water Soluble Powder Decontrolled 02 Approved
Pharmaceutical Each 100g powder contains:- 100g years
Industries, Rawat, Enrofloxacin HCI……..10% 250g
Islamabad. Amantadine HCI………4% 500g
Colistin Sulphate………3% 1 Kg
(Antibacterial, Antiviral). 5 Kg
10Kg
25Kg

16. M/s. Inshal Adekshell Water Soluble Powder Decontrolled 02 Deferred, for
Pharmaceutical Each 1000g contains:- 30g years PSI by panel
Industries, Rawat, Vitamin A……………..20 MIU 50g comprising of
Islamabad. Vitamin D……………...2 MIU 100g Area FID and
Vitamin E……………....6g 250g A.Q.Javed
Vitamin K3……………..5g 500g Iqbal Member
(Multivitamins). 1 Kg RB.
5 Kg
10Kg

17. M/s. Inshal Shelldox Water Soluble Powder Decontrolled 02 Approved

Pharmaceutical Each 1000gm contains:- 100g years
Industries, Rawat, Doxycycline HCI…………400g 250g
Islamabad. Tylosin Tartrate…………..200g 500g
(Antibacterial, Anti-viral). 1 Kg

10
 5 Kg
10Kg

18. M/s. Inshal OXY NEO 10/10 Water Soluble Decontrolled 03 Approved
Pharmaceutical Powder 30g years
Industries, Rawat, Each 100g contains:- 50g
Islamabad. Neomycin Sulphate……..10g 100g
Oxytetracycline HCI…….10g 125g
(Anti-infective, Antibacterial). 250g
500g
1 Kg
5 Kg

19. M/s. Inshal Levashell 15 Powder Decontrolled 02 Approved

Pharmaceutical Each 100gm contains:- 30g years
Industries, Rawat, Levamisole HCI……….15% 50g
Islamabad. (Anthalmintic). 100g
250g
500g
1 Kg
5 Kg
10Kg

20. M/s. Inshal Tifo Shell Powder Decontrolled 02 Approved

Pharmaceutical Each 100gm contains:- 30g years
Industries, Rawat, Trichlorfon…………98% 50g
Islamabad. (Antiparasites, Anti Helminths). 100g
500g
1 Kg
2.5Kg
5 Kg
10Kg
25Kg

21. M/s. Inshal Pipra Shell Water Soluble Powder Decontrolled 02 Approved,
Pharmaceutical Each 1000g contains:- 100g years with brand
Industries, Rawat, Piprazine Citrate………..1000g 250g name change
Islamabad. (Anthelmintics). 500g
1 Kg
5 Kg
10Kg
22. M/s. Inshal Enrodine Plus Water Soluble Decontrolled 02 Approved,
Pharmaceutical Powder 100g years with brand
Industries, Rawat, Each 1000g contains:- 250g name change
Islamabad. Enrofloxacin………..100g 500g
Amantadine HCI……40g 1 Kg
Colistin Sulphate……35g 5 Kg
(Antibacterial, Anti-viral). 10Kg

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23. M/s. Inshal Sulpha Plus Water Soluble Powder Decontrolled 02 Approved
Pharmaceutical Each 100gm powder contains:- 100g years
Industries, Rawat, Enrofloxacin………….10% 250g
Islamabad. Amantadine HCI………4% 500g
Colistin Sulphate………4% 1 Kg
(Antibacterial, Anti-Viral). 5 Kg
10 Kg
25 Kg

24. M/s. Inshal Amino Flush Water Soluble Decontrolled 02 Approved

Pharmaceutical Powder 100g years
Industries, Rawat, Each 100g contains:- 250g
Islamabad. Ammonium Chloride………45g 500g
Sodium Sulphate…………..25g 1 Kg
Magnesium Sulphate 5 Kg
7H2O....................................25g 10Kg
(Aminoacid, Multi-Vitamin,
Expectorant).

25. M/s. Inshal Reno Shell Water Soluble Powder Decontrolled 02 Deferred for
Pharmaceutical Each 100g contains:- 30g years application on
Industries, Rawat, Methanamine…………90g 50g Form 5 D
Islamabad. Sorbitol………………..5g 100g along with
(Aminoacid, Multi-Vitamin, 250g revised Fee
Expectorant). 500g, and expert
1 Kg views of
5 Kg following;
10Kg g. Dr. M
Ashraf,
UVAS
h. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
26. M/s. Inshal Vita Shell Water Soluble Powder Decontrolled 02 Approved
Pharmaceutical Each 1000gm powder contains:- 30g years
Industries, Rawat, Vitamin C………………200g 50g
Islamabad. Acetylecylicic Acid…….67g 100g
Potassium Chloride……..3g 250g
Sodium Citrate………….7g 500g
(NSAIDs + Suppliment). 1 Kg
5 Kg
10Kg
25Kg

27. M/s. Inshal Coxishell Water Soluble Powder Decontrolled 02 Approved

12
 Pharmaceutical Each 1000g powder contains:- 30g years
Industries, Rawat, Doxycycline HCI………..200g 50g
Islamabad. Tylosin Tartrate………….100g 100g
Bromhexine………………5g 250g
(Antibacterial, Anti-Viral). 500g
1 Kg
5 Kg
10Kg
25Kg

28. M/s. Inshal Amproshell 60% Water Soluble Decontrolled 02 Approved

Pharmaceutical Powder 100g years
Industries, Rawat, Each 100gm powder contains:- 500g
Islamabad. Amprolium Hcl………60gm 1 Kg
Coccididal).

29. M/s. Inshal Tetra Shell 20 Water Soluble Decontrolled 02 Approved

Pharmaceutical Powder 30g years
Industries, Rawat, Each 1000g contains:- 50g
Islamabad. Chlortetracycline HCI……..200gm 100g
(Anti-infective, Antibacterial, 150g
Tetracycline). 200g
250g
500g
1 Kg

30. M/s. Inshal Tilco Shell Water Soluble Powder Decontrolled 02 Deferred for
Pharmaceutical Each 1000g contains:- 30g years application on
Industries, Rawat, Tilmicosin Phosphate…….10% 50g Form 5 D
Islamabad. (Anti-infective, Antibacterial). 100g along with
500g revised Fee
1 Kg and expert
2.5Kg views of
5Kg following;
10Kg i. Dr. M
25Kg Ashraf,
UVAS
j. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
31. M/s. Inshal Doxyline Water Soluble Powder Decontrolled 02 Approved
Pharmaceutical Each 1000gm powder contains:- 30g years
Industries, Rawat, Doxycycline HCI………200g 50g
Islamabad. Tylosin Tartrate………..100g 100g
Colistin Sulphate…….450MIU 250g

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 Bromhexine HCI…….….4g 500g
(Antibacterial, Anti-Viral). 1 Kg
5 Kg
10 Kg
25Kg

32. M/s. Prix Pri-Dimidine 33.3% Injection Decontrolled 02 Approved

Pharmaceutica Each ml injection contains:- 100ml years
(Pvt) Ltd Lahore. Sulphadimidine 500ml
Sodium……………….333.3mg
(Sulphonamide).

33. M/s. Prix Pri-Calcifort injection Decontrolled 02 Deferred for

Pharmaceutica Each 100 ml injectable solution 50ml years application on
(Pvt) Ltd Lahore. contains:- 100ml Form 5 D
Calcium gluconate………20g 250ml along with
Toldimphos sodium…….400mg 500ml revised Fee
Magnesium sodium…….334mg and expert
Baric acid………………..2.4g views of
Sorbitol………………….5g following;
(MineralsCalcium/Phosphrous/Ma k. Dr. M
gnesium and Sugar) Ashraf,
UVAS
l. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
34. M/s. Prix PRI-Dolocam 7.5 Injection Decontrolled 02 Approved
Pharmaceutica Each ml contains:- 5 x 10ml years
(Pvt) Ltd Lahore. Meloxicam………7.5mg 25ml
(NSAID) 50ml
100ml

35. M/s. Prix Pri-Deflame 5 Injection Decontrolled 02 Approved

Pharmaceutica Each ml injection 5x 10ml years
(Pvt) Ltd Lahore. contains: - 20ml
Flunixin Meglumine…..50mg 50ml
(Nsaid) 100ml

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36. M/s. Epoch Escour Oral Suspension Decontrolled 2 years Approved
Pharmaceuticals, Each ml contains:- 100ml
Karachi. Sulphadiazine BP……35.50mg 500ml
Sulphadimidine BP…28.40mg
Neomycin Sulphate BP1.80mg
Hysoine
Methylbromide…….0.040mg
Pectin USP…………7.1mg
Kaolin BP……………103.3mg
Vitamin B1 BP………0.150mg
Vitamin B2 BP………0.220mg
(Antibiotic, Anti-Toxins, anti-
spasmodic and Vitamins).

37. M/s. Epoch Epotizer Injection Decontrolled 18 Approved

Pharmaceuticals, Each 3ml contains:- 50ml months
Karachi. Thiamine HCI (Vitamin 100ml
B1)…………………..100mg
Pyridoxine Hydrochloride
(Vitamin
B6)…………………100mg
Cyanocobalamin (Vitamin
B12)…………………500mcg
(Vitamins).

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 Registration-II.
Registration Applications of July, 2010.

S.No. Name of Name of drug(s) & Proposed Demanded Date of Decision

firm(s) Composition Pack size Price application,
Diary No. &
Form
1. M/s Barret DiaSet Plus Tablet As per As per 28-7-2010 Approved
Hodgson, Each tablet contains: PRC PRC Dy.No.1433
Karachi Pioglitazone ……15 mg Form-5
Metformin Rs.8000/-
Hydrochloride…...850 mg Rs.12,000/-
(Antidiabetic agent) 21-5-2013
2. M/s Nabi 01/07/2010 Approved
Qasim Reliefal 6 Plus Suspension Dy. No. 1273
Karachi Each 5ml contains: 60ml As per Form 5
Paracetamol BP……….250mg 450ml PRC Rs. 8000/-
(analgesic & antipyretic) Rs.12,000/1
14-5-2013
3. M/s Bosch Bentocin 30mg Injection 5’s Rs.75/- 22-07-2010 Deferred
Pharmaceut Each vial contains: 10’s Rs.150/- Dy.No.1388 being
icals, Kar. Pentazocin As Form-5 Controlled
lactate…………...…30 mg Rs.8000/- Drug
(Narcotic analgesic, post Rs.12,000/-
operative pain) 20-5-2013
4. M/s Barrett Ivabar 7.5mg Tablet 10’s Rs.1950/- 10/07/2013 Deferred for
Hodgson Each tablet contains: 14’s Rs.2730/- Dy. No. 691 i.submission of
Karachi Ivabradine Hydrochloride eq. 28’s Rs.5460/- Form 5D remaining fee.
to Ivabradine……...7.5mg 56’s Rs.10,920/- Rs. 60,000/- ii.
(Anti anginal, anti heart Fast track Confirmation
for approval by
failure) application USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
5. -do- Ivabar 5mg Tablet 10’s Rs.1740/- 10/07/2013 -Do-
Each tablet contains: 14’s Rs.2436/- Dy. No. 690

16
 Ivabradine Hydrochloride eq. 28’s Rs.4872/- Form 5D
to Ivabradine………...5mg 56’s Rs.9744/- Rs. 60,000/-
(Anti anginal, anti heart Fast track
failure) application

6. M/s Clogrel Plus Tablet 10x2’s As per 01/07/2013 Deferred for

Pharmatec Each film coated tablet PRC Dy. No. 683 product
Pakistan contains: Form 5 specifi
Pvt. Ltd. Aspirin (enteric coated Rs. 60,000/- inspection for
Kar. pellets)………………..75 mg Fast track confirmation
Clopidogrel (as Clopidogrel application of
Bisulphate USP)……..75 mg manufacturin
(Anticoagulant/ antiplatelet) g & QC
facility by
area FID &
Director
DTL, Karachi

Registration Applications of August, 2010.

S.No. Name of Name of drug(s) & Proposed Demanded Date of Comments
firm(s) Composition Pack size Price application,
Diary No. &
Form
7. M/s Nabi Letol Tablet 10’s & As per 11-08-2010 Deferred for
Qasim Each film coated tablet 20’s PRC Dy.No.1553 i.submission of
Karachi contains: Form-5 application on
Labetalol Rs.8000/- Form5D. ii.
Hydrochloride …200mg Rs.12,000/- Confirmation
for approval by
(Beta Blockers) 14-5-2013
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion by
Brig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
8. -do- Loprot Plus Capsule 7’s As per 03-08-2010 Referred to
Each capsule contains:- 10’s PRC Dy.No.1530 review
Omeprazole ……..20mg 14’s Form-5 committee
Sodium Bicarbonate .1100mg Rs.8000

17
 (Anti Ulcerant) Rs.12,000/
14-5-2013
9. -do- Letol Tablet 10’s & As per 11-08-2010 Deferred for
Each film coated tablet 20’s PRC Dy.No.1554 i.submission of
contains: Form-5 application on
Labetalol Rs.8000/- Form5D. ii.
Hydrochloride USP…300mg Rs.12,000/1 Confirmation
for approval by
(Beta Blockers) 14-5-2013
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
10 -do- Misotec tablet 10’s & 30 As per 17-08-2010 Approved
Each tablet contains: PRC Dy.No.1578
Misoprostol…100mcg Form-5
Mfg.Specs.NQ Rs.8000/-
(Prostaglandin Analogue) Rs.12,000/1
14-5-2013
11 -do- Misotec tablet 3 &10’s As per 17-08-2010 Approved
Each tablet contains: PRC Dy.No.1577
Misoprostol…200mcg Form-5
Mfg.Specs.NQ Rs.8000/-
(Prostaglandin Analogue) Rs.12,000/1
14-5-2013
12 -do- Tensel 5mg Tab. 14’s As Per 10-08-2010 Approved
Each tablet contains: PAC 1540
Nebivolol HCI equivalent to Form-5
Nebivolol…….5mg Rs.8000/-
(Anti-hypertensive) Rs.12,000/1
14-5-2013
13 -do- Letol Tablet 20’s As per 11-08-2010 Approved
Each film coated tablet PRC Dy.No.1556
contains: Form-5
Labetalol Rs.8000/-
Hydrochloride ….…100 mg Rs.12,000/1
(Beta Blockers) 14-5-2013

Applications for Fast Track Registration

18
S.No. Name of Name of drug(s) & Proposed Demanded Date of Comments
firm(s) Composition Pack size Price application,
Diary No. &
Form
14 M/s Indus Dyclo Plus 2ml Inj. 5’s Rs.140/- 13-05-2013 Approved.
Pharma Each 2ml contains: 10’s 280/- Dy.No.367 Only IM
Karachi Diclofenac Sodium ..75 mg 20’s Rs.560/- Form-5 route of
Lignocaine Rs.60,000/- administratio
Hydrochloride……..20mg n approved
(Non Steroidal Anti-
Inflammatory)
15 -do- I-Flor 250mg Schet 10’s Rs.480/- 13-05-2013 Referred to
Each sachet contains: Dy.No.366 H&OTC
Saccharomyces Form-5 Division
Boulardii………….250 mg Rs.60,000/- being
(Anti diarrheal) probiotics
16 M/S. GSK Panadol sinus Caplets 100’s Rs.300/- 24-07-2013 Deferred for
Pakistan Each Caplet contains:- Dy.No.1047 submission of
Ltd. Paracetamol……. 500 mg Form-5 application on
Karachi. Phenylephrine HCl. 5.00mg Rs,60,000/- Form5D &
(Cold Preparation) remaining fee.

17 M/s Sante Cipromax 250mg Tablet 10’s As per 14-05-2013 Approved.

Pvt. Ltd, Each tablet contains: PRC Dy.No.371 The Board
Karachi Ciprofloxacin HCl eq. to Form-5 advised to
Ciprofloxacin……..250 mg Rs.60,000/- change brand
(Fluoroquinolone) name.
18 M/s Sepride Tablet 10’s As per 20-05-2013 Approved
Medisure Each tablet contains: 50’s PRC Dy.No.498
Lab. Kar. Cinitapride…….….1 mg Form-5
(Antiemetic) Rs.60,000/-
19 -do- Dexiprofen Tablet 10’s As per 20-05-2013 Approved
Each tablet contains: 30’s PRC Dy.No.496
Dexibuprofen…….300 mg Form-5
(Analgesic agent) Rs.60,000/-
20 -do- Dexiprofen Tablet 10’s As per 20-05-2013 Approved
Each tablet contains: 30’s PRC Dy.No.497
Dexibuprofen…..400 mg Form-5
(Analgesic agent) Rs.60,000/-
21 M/s S.J & Berica 60mg Tablet 14’s Rs.600/- 29-04-2013 Approved
G, Karachi Each film coated tablet 273
contains: Form-5
Etoricoxib…….…60 mg Rs.20,000/-
(NSAID) Rs.40,000/-
20-05-2013

19
22 -do- Acenac 150mg Injection 5x1ml Rs.200/- 20-05-2013 Approved
Each ml contains: 273
Aceclofenac…….150 mg Form-5
(Non-Steroidal Anti Rs.20,000/-
inflammatory drug) Rs.40,000/-
20-05-2013
23 M/s Sami D3 Injection As per As per 20-05-2013 Approved.
Pharmaceuti Each ml contains: PRC PRC 518 The Board
cals, Kar. Cholecalciferol …...5 mg Form-5 advised to
(200,000 IU) Rs.60,000/- change brand
(Vitamin D3) name.
24 M/s Helix Azil 40mg Tablet 10’s As per 20-05-2013 Deferred for i.
Pharma kar. Each tablet contains: 30’s PRC 515 Confirmation
Azilsartan kamedoxomil Form-5D for approval by
eq.to Azilsartan Rs.60,000/- USFDA,
medoxomil……..40 mg Rs.90,000/- EMA,
regulatory
(Anti Hypertensive) 24-07-2013
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
25 -do- Azil 80mg Tablet 10’s As per 20-05-2013 -Do-
Each tablet contains: 30’s PRC 514
Azilsartan kamedoxomil Form-5D
eq.to Azilsartan Rs.60,000/-
medoxomil………80 mg Rs.90,000/-
(Anti Hypertensive) 24-07-2013
26 -do- Azil 20mg Tablet 10’s As per 20-05-2013 -Do-
Each tablet contains: 30’s PRC 513
Azilsartan kamedoxomil Form-5D
eq.to Azilsartan Rs.60,000/-
medoxomil………20 mg Rs.90,000/-
(Anti Hypertensive) 24-07-2013
27 M/s Tramorhage 250mg 20’s Rs.154/- 20-05-2013 Approved
Mediate Capsule 502
Pharmaceuti Each capsule contains: Form-5
cals, kar Tranexamic acid...250 mg Rs.20,000/-
Rs.40,000/-
23-5-2013
28 -do- Tramorhage 500mg 20’s Rs.310/- 20-05-2013 Approved
Capsule 501

20
 Each capsule contains: Form-5
Tranexamic acid…..500 mg Rs.20,000/-
Rs.40,000/-
23-5-2013
29 -do- Medeiron-S Injection 5mlx5’s Rs.1250/- 20-05-2013 Approved.
20mg/ml Injection 500 The Board
Each ml contains: Form-5 advised to
Iron sucrose…….…20 mg Rs.20,000/- change brand
name.
30 M/s Maple Losaan 25mg Tablet 20’s As per 21-05-2013 Approved
Pharma. Each tablet contains: PRC 526
Kar. Losartan Potassium...25 mg Form-5
(Anti hypertensive) Rs.60,000/-
31 -do- Ciprozee 750mg Tablet 10’s As per 21-05-2013 Approved
Each tablet contains: PRC 525
Ciprofloxacin (as Form-5
Hydrochloride)……750 mg Rs.60,000/-
(Fluoroquinolone
Antibiotic)
32 M/s Opal Febutab 80mg Tablet 10’s As per 04-06-2013 Approved
Lab. Each film coated tablet 20’s PRC Dy.No.631
Karachi contains: 30’s Form-5
Febusostat…………..80 mg Rs.60,000/-
(Xanthine Oxidase
Inhibitor)
33 M/s Helix Lacosa 200mg Tablet 14’s As per 17-06-2013 Approved
Pharma Each film coated tablet PRC Dy.No.664
Karachi contains: Form-5
Lacosamide……….200 mg Rs.60,000/-
(Anti epileptic/ Anti-
Convulsant)
34 -do- Lacosa 100mg Tablet 14’s As per 17-06-2013 Approved
Each film coated tablet PRC Dy.No.663
contains: Form-5
Lacosamide……….100 mg Rs.60,000/-
(Anti epileptic/ Anti-
Convulsant)
35 -do- Lacosa 50mg Tablet 14’s As per 17-06-2013 Approved
Each film coated tablet PRC Dy.No.665
contains: Form-5
Lacosamide……….50 mg Rs.60,000/-
(Anti epileptic/ Anti-
Convulsant)
36 -do- Rozerem Tablet 10’s As per 04-06-2013 Deferred for i.
Each film coated tablet 30’s PRC Dy.No.633 Confirmation
contains: Form-5D for approval by

21
 Ramelteon………..8 mg Rs.150,000/- USFDA,
(Hypnotics) EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion by
Brig.
M.H.Najmi,
Dr.Rizwan
Taj, PIMS
Dr.Saleem
Jehangeer, MH
Rawalpindi
37 M/s Alptec 0.5mg Tablet 3x10’s As per 03-06-2013 Deferred
Pharmatec Each tablet contains: PRC Dy.No.616 being
Pak. Alprazolam ………..0.5 mg Form-5 controlled
Karachi (Anxiolytic) Rs.60,000/- Drug
38 -do- Reltus Forte Cough 120ml As per 07-06-2013 Deferred
Expectorant PRC Dy.No.640 being
Each 5ml contains: Form-5 controlled
Ammonium Rs.60,000/- Drug
chloride……….100mg
Ephedrine
Hydrochloride……7 mg
Chlorpheniramine
maleate…………..2 mg
(Cpigj ex[ectprant)
39 M/s Sanofi Aprovasc 300/10mg Tablet 28’s Rs.2212/- 04-06-2013 Deferred for i.
Aventis, Each tablet contains: Dy.No.630 Confirmation
Karachi Irbesartan……….300 mg Form-5D for approval by
Amlodipine besylate.14 mg Rs.150,000/- USFDA,
eq. to amlodipine…10 mg EMA,
regulatory
(Alntihypertensive,
body of Japan
angiotensin II receptor or Australia. ii.
antagonist) Expert opinion
by Brig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
40 -do- Aprovasc 150/10mg Tablet 28’s Rs.2620.8/- 04-06-2013 -Do-
Each tablet contains: Dy.No.624
Irbesartan……….150 mg Form-5D
Amlodipine besylate.14 mg Rs.150,000/-
eq. to amlodipine…10 mg

22
 (Alntihypertensive,
angiotensin II receptor
antagonist)
41 -do- Aprovasc 150/5mg Tablet 28’s Rs.1456/- 04-06-2013 -Do-
Each tablet contains: Dy.No.631
Irbesartan……….150 mg Form-5D
Amlodipine besylate.7 mg Rs.150,000/-
eq. to amlodipine……5 mg
(Alntihypertensive,
angiotensin II receptor
antagonist)
42 -do- Aprovasc 300/5mg Tablet 28’s Rs.2114/- 04-06-2013 -Do-
Each tablet contains: Dy.No.628
Irbesartan……….300 mg Form-5D
Amlodipine besylate.7 mg Rs.150,000/-
eq. to amlodipine……5 mg
(Alntihypertensive,
angiotensin II receptor
antagonist)
43 M/s Abbott Rondec E Syrup 60ml Rs.60/- 07-06-2013 Deferred for i.
Laboratorie Each 5ml contains: 120ml Rs.120/- Dy.No.639 Confirmation
s, kar. Salbutamol………….2 mg Form-5D for approval by
Guaifenesin ……..200 mg Rs.150,000/- USFDA,
Bromhexine HCl…….4mg EMA,
regulatory
(Expectorant with
body of Japan
bronchodilator cough or Australia. ii.
syrup) Expert opinion
by Brig. Aslam
Khan,
Dr.Rehana
Kausar, PIMS
Head, Dept of
Chest
Diseases,
Shaikh Zayed
Hospital,
Lahore

44 M/s Barrett Megaklar DS Suspension 60ml Rs.450/- 27-06-2013 Deferred for

Hodgson 250mg/ml Dy.No.675 confirmation
Pak. Kar. Each 5ml contains: Form-5 whether
Clarithromycin*…250mg Rs.60,000/- powder or
(Antibacterial and granules
Antibiotic)

23
Item No.III Miscellaneous Cases:

Registration-I

Case No:01 Transfer of Registration of Drugs from M/s. Pakistan Business

International, Karachi to M/s. Zenith International, Karachi.

M/s. Zenith International, Karachi have requested for transfer of registration of

the following registered Surgical Sutures from the name of previous agent M/s. Pakistan
Business International, Karachi to their name for import and approved the change of
manufacturer’s name of the products from M/s. Shandong Shanxian Medical Suture
Materials Co. Ltd. China to M/s. Shandong Sinorgmed Co. Ltd., China:-

S. No. Reg. No. Name of Products.

1. 031371 PLAIN CATGUT (Plain Catgut Surgical Sutures).
2. 031372 CHROMIC CATGUT (Chromic Catgut Surgical
Sutures).
3. 031373 POLYGLYCOLIC ACID (Synthetic Absorbable
Sutures).
4. 031374 SILK BRAIDED (Silk Braided Surgical Sutures).
5. 043055 Black Monofilament Nylon Surgical Suture.
6. 043056 Blue Polypropylene Surgical Suture.
7. 043057 Green Braided Polyester Surgical Suture.

The firm has deposited the fee Rs.15000 x 7 = Rs.105000/- and submitted
following supporting documents:-
i. No objection certificate to transfer the registration in the name of M/s.
Zenith International, Karachi from the manufacturer abroad M/s.
Shandong Sinorgmed Co. Ltd., China.
ii. Manufacturer declaration regarding termination of their previous agency.
iii. Manufacturer declaration of change in company name.
iv. Certificate from Heze Food and Drug Administration of Peoples Republic
of China certifying the change in company name.

No Objection Certificate of the former agent M/s. Pakistan Business International,

Karachi was not provided. M/s. Pakistan Business International, Karachi was asked either
to submit their NOC in this regard or provide their fresh agency agreement (if any) with
the manufacturer abroad. They have informed that they do have strong objection in
transferring the said drugs to other applicant/company without their consent and shall be

24
furnishing fresh Agency Agreement and relevant documents as soon as they receive.
However the principals abroad M/s. Shandong Sinorgmed Co. Ltd., China have
meanwhile confirmed that they have appointed M/s. Zenith International, Karachi as their
sole agent for all their products and have terminated their agency with M/s. Pakistan
Business International, Karachi.
Show Cause Notices were issued to M/s. Pakistan Business International, Karachi
two times for cancellation of registration of said drugs from their name. In response they
have requested to grant them an appointment to appear in person to explain the details.
They have also informed that they already pursue the matter with Wafaqi
Mohtasib (Ombudsman’s) Secretariat Regional Office Karachi to counter the challenges
and forward copies of proceedings as and when required by this office.

M/s Zenith International, Karachi have submitted relevant documents from

manufacturer abroad that are not endorsed by Pakistan embassy in China.

Accordingly, M/s. Pakistan Business International, Karachi was called for

personal hearing before the Drug Registration Board in its 237th meeting held on 26-02-
2013.

In response, M/s. Pakistan Business International, Karachi have submitted that the
letter for personal hearing received too late leaving no time, not even a single day to
move / attend the scheduled hearing before Drug Registration Board on 26th February,
2013.

The Drug Registration Board in its 237th meeting held on 26-02-2013 and also
placed in 238th meeting held on August 5-6, 2013 the board considered and deferred the
case and decided to issue final show cause notice to call the firm for personal hearing in
next board’s meeting.
Decision:
The representative of the firm Mian Abdul Jabbar CEO appeared before the
Board and informed that his firm i.e. M/s. Pakistan Business International, Karachi
is still authorized agent of M/s. Shandong Sinorgmed Co. Ltd., China for above
referred products and requested for two week time for submission of legalized New
Sole agency agreement from M/s. Shandong Sinorgmed Co. Ltd., China. The Board

25
after detailed deliberations allowed him to submit the same within 15 days for
further actions on the request of M/s. Zenith International, Karachi.

Case No:02. Re-registration of BONEFOS Capsules (REG. NO.013031).

On the request of M/s. Medipharm (Private) Limited, Karachi the Drug
Registration Board in its 236th meeting held on 20th November, 2012 de-registered their
drug “Bonefos Capsules (Disodium Clodronate 400mg) (Reg. No. 013466)” due to non-
available business with immediate effect.
Now M/s. Medipharm (Private) Limited, Karachi have informed that they have
two presentations of Bonefos Capsules, registered with DRAP Bonefos Capsules, 1x
100’s pack and Bonefos Capsules, 1x30’s pack. They have pointed out that they applied
for withdrawal / discontinue one of the above mentioned presentations i.e., Bonefos
Capsules, 1x100’s pack, with the intention to continue with the sale of Bonefos Capsules
1x30’s. Unintentionally wrong registration number was mentioned which was corrected
in subsequent clarification letter.

Now surprisingly, they have received the letter with the subject, “de-registration
of drug” in which there are two main confusions:-

i) The registration number (013466) mentioned is not of Bonefos capsules,

but of another unrelated product.
ii) The letter does mention Bonefos Capsule but confusingly does not
mention the de-registration presentation, i.e., Bonefos Capsules, 1x100’s
pack. While they had clearly mentioned the desired pack size in their
request letter.

They have stopped further sales of Bonefos Capsules. To avoid any further
confusion, they have requested:-

i) Please confirm withdrawal / discontinuation of Bonefos Capsules 1x100’s

presentation.
ii) Please confirm continued registration of Bonefos Capsules 1x30’s pack
size having Registration No.013031 so that it can continue to be marketed.

26
 The firm has submitted that Bonefos is used on long term basis, in life threatening
cancers, so to avoid any inconvenience to the patients already on Bonefos Capsules
requested to treats this matter at the earliest.

Decision:
The Board after detailed discussion accepted the request of the firm for re-
registration of Bonefos Capsules (Registration No. 013031) in pack size of 30’s on
same terms and conditions.

Case No:03. APPEAL FILED BY M/S. FINE TRADERS INTERNATIONAL

AGAINST THE DECISION OF REGISTRATION BOARD REGARDING
REJECTION OF REGISTRATION APPLICATION OF NEOCLOXIN
POWDER.

The Drug Registration Board in its 210th meeting held on 26th – 27th October,
2007 considered and rejected the application of “Neocloxin Powder” applied by M/s.
Fine Traders International Faisalabad for import from M/s. Agrar Holland BV Holland
due to irrational formulation.
Against the decision of Drug Registration Board M/s. Fine Traders International
Faisalabad filed an appeal before the Drugs Appellate Board. The Drugs Appellate Board
in its 138th meeting held on 13-01-2010 considered and passed orders on the appeal
preferred by the firm against the decision of the Drug Registration Board regarding
rejection of their application for grant of registration due to the reason as follows: -
Name of Drug (s) & Composition. Orders Passed by the Drugs Appellate Board.
Neocloxin Powder After hearing to arguments of the appellant and
Each gm contains: - the basis of decision by the respondent i.e. the
Oxytetracycline HCl 100mg. Registration Board as stated by its secretary and
Neomycin Sulphate 50mg. taking into consideration all the relevant pros and
Chloramphenicol 100mg. cons of the matter, the Board decided to remand
the case back to the Registration Board for
getting expert evaluation of this formulation from
University of Veterinary and Health Sciences,
Lahore and also to verify its formulation in other
countries and to decide the matter on merit
accordingly.

27
 The Drug Registration Board in its 226th meeting held on 20th & 21st July 2010
considered and decided that the instructions of the Drugs Appellate Board be processed
accordingly.
As per decision of the Drug Registration Board in its 226th meeting held on 20th &
21st July 2010 case was referred to Prof. Dr. Muhammad Nawaz, Vice Chancellor,
University of Veterinary and Health Sciences, Lahore for their detailed views/expert
opinion and recommendations on the matter. The views/expert opinion of Prof. Dr.
Muhammad Nawaz is not received so far.

Decision:
The Board discussed the matter in detail. Dr. Arshad, Member DRB also
recommended that chloramphenicol containing formulation should be banned in
veterinary drugs. Thus the Board rejected the request of the firm. The Board
further decided to issue cuase notices to all manufactures / importers of veterinary
drugs for de-registration of all chloramphenicol containing products.

Case No:04. Correction in Composition of Solvasole Forte Injection.

M/s. Mylab (Private) Limited, Bahawalpur have requested for correction of

composition of their registered veterinary drug “Solvasol Forte Injection (Reg.
No.075602)” that one of the ingredient “Etilefrine 10mg/ml” is written by mistake in the
registration application instead of “Etilefrine 0.2mg/ml”. They have therefore requested
for correction of composition of the product as follows. M/s. Mylab (Private) Limited,
Bahawalpur have deposited required fee Rs.20000/-:-

Incorrect composition Correct composition

Solvasol Forte Injection. Solvasol Forte Injection.
Each ml contains:- Each ml contains:-
Novaminsulfon …………….. .40mg. Novaminsulfon …………….. .40mg.
Etilefrin…………………….10mg. Etilefrin……………………0.2mg.
Calcium Gluconate …………100mg. Calcium Gluconate …………100mg.
Magnesium Gluconate ……… 10mg. Magnesium Gluconate ……… 10mg.
Sodium Salicylate …………… 7mg. Sodium Salicylate …………… 7mg.
Nicotinamide ………………… 0.3mg. Nicotinamide ………………… 0.3mg.
Caffeine………………………. 10mg. Caffeine………………………. 10mg.

28
 Boric acid………………………10mg. Boric acid………………………10mg.

The firm have further requested that the above composition is already registered
and is a Mee-Too product. They have given the following references of already registered
products:-

S. No. Name of Manufacturer. Name of Product. Reg. No.

1. M/s. Nawan Laboratories, Karachi Nevit Forte Injection 058987
2. M/s. Selmore Pharmaceuticals, Lahore Aminox Injection 029663
3. M/s. Star Laboratories, Lahore Novastar Injection 035134
4. M/s. Zakfas Pharma, Multan Novafon 052325

Keeping in view of above submitted documents request of the firm for correction
of composition of the drug “Solvasol Forte Injection (Reg. No.075602)” may be
considered for approval please.
Decision:
Request of the firm was approved by the Board
.
Case No:05. Change of Manufacturing Site of Tarceva Tablets.

M/s. Roche Pakistan Limited, Karachi have requested to approve the change of
manufacturing site of their following registered imported drugs from M/s. F. Hoffmann-
La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy:-

S. No. Reg. No. Name of Drug (s).

1. 043002 Tarceva 100mg Tablets.
Each film-coated tablet contains:-
Erlotinib hydrochloride corresponding to
100mg of Erlotinib.

2. 043003 Tarceva 150mg Tablets.

Each film-coated tablet contains:-
Erlotinib hydrochloride corresponding to
150mg of Erlotinib.

29
 M/s. Roche Pakistan Limited, Karachi has deposited required fee submitted
following supporting documents:-
i) Copy of initial registration letter.
ii) Copy of change of manufacturing site.
iii) Copy of last renewal of drugs.
iv) Original COPP of drugs issued by EMA.
M/s. Roche Pakistan Limited, Karachi was advised to confirm about status of
Tarceva 25mg Tablets (Reg. No.043001) whether it will be supplied from previous
manufacturing site. In response, M/s. Roche Pakistan Limited, Karachi have submitted
that “Tarceva 25mg Tablets” strength is not prescribed by specialist doctors, which
leaves it with no place in the market; therefore they do not intend to continue marketing
this strength.
Keeping in view the submitted documents request of the firm for change of
manufacturing site from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.
Roche S.p.A., Segrate (Milano), Italy is submitted for consideration of the Drug
Registration Board.
Decision:
The Board after discussion approved the change in manufacturing site of
Tarceva tablets from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.
Roche S.p.A., Segrate (Milano), Italy. However the Board advised to provide site
master file of new manufacturing site and authorized its Chairman to accord
approval for issuance of letter.

Case No:06. Change of Manufacturing Site of Integrilin Injections.

M/s. Schering-Plough Pakistan (Pvt) Limited, Karachi have requested to approve

the change of manufacturing site of their following registered imported drugs from M/s.
Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy, while
the Labeling, Secondary Packaging and Batch release site of the finished products remain
the same i.e. M/s. Schering-Plough Labo N.V., Belgium:-

S. No. Reg. No. Name of Drugs.

1. 033145 Integrilin 0.75mg/ml Injection.

30
 2. 033146 Integrilin 2.0mg/ml Injection.

They have deposited required fee and submitted following documents in support
of their request:-
i) Original declaration letter from their parent company M/s. Schering-
Plough Corporation, USA affecting this change requirement.
ii) Patheon’s GMP and Manufacturing Certificates duly notarized and
legalized in original by Pakistan embassy, Rome, Italy.
iii) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from
Italy for Integrilin 0.75mg/ml Injection.
iv) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from
Italy for Integrilin 2.0mg/ml Injection.
v) FDA approval of Integrilin 0.75mg/ml &2.0mg/ml in US.
vi) Notarized Merck letter confirming availability of Integrilin in US from the
manufacturing site Patheon Italia S.p.A. Ferentino, Italy.
vii) Legalized and Notarized FDA approval of Integrilin with the source of
supply Patheon Italia S.p.A in US.

The Registration of the drug is valid till 16th December 2013 as change in the
name of manufacturing site was approved on 17th December 2008.
Keeping in view the submitted documents request of the firm for change
of manufacturing site from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon
Italia SPA, Ferentino, Italy is submitted for consideration of the Drug Registration Board.

Decision:
The Board approved the change in manufacturing site of Integrilin
Injection from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia
SPA, Ferentino, Italy, while the labeling, secondary packaging and batch release site
of the finished products remain the same i.e. M/s. Schering-Plough Labo N.V.,
Belgium. However the Board advised to provide site master file of new
manufacturing site and authorized its Chairman to accord approval for issuance of
letter.

31
Case No: 07. Transfer of Registration of Imported Drugs and Change of
manufacturing site.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer
of registration of the under-mentioned registered imported drugs from the name of
previous importer M/s. Highnoon Laboratories Ltd., Lahore to their name as due to an
International Acquisition of the Pharmaceutical Section of Solvay with all associated
companies has been acquired by the Abbott group since February 15, 2010: -

S# Reg. Name of Drugs. Existing Name of New Name of

No. Manufacturer. Manufacturer.
1. 018552 Physiotens 0.2mg M/s. Eli Lilly S.A., Manufactured by: M/s.
Spain. Rottendrof Pharma GmbH,
Tablets.
Germany.
Packed by: -
M/s. Abbott Healthcare
SAS, France.
2. 018551 Physiotens 0.3mg -do- -do-
Tablets.

3. 018550 Physiotens 0.4mg -do- -do-

Tablets.

They have deposited required fee and submitted following supporting documents:
-
i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd.,
Lahore.
ii) Copy of the acknowledgement of last renewal of registration of the
products applied by the previous importer M/s. Highnoon Laboratories
Ltd., Lahore.
iii) Copies of acknowledgement of receipt issued by the German National
authority BfArM & a notification submitted by the Solvay to the Germany
authority for the change in manufacturer name to M/s. Rottendrof Pharma
GmbH, Germany.
iv) Copy of NOC for CRF.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi was advised to provide the

32
proof of approval of the “Physiotens tablets” from EMA, US FDA, Japan & WHO form
the same source, the product is not approved from any of these regulatory bodies and as
per Import Policy the inspection of the source is required before transfer.
The case is submitted for consideration of the Drug Registration Board.

Decision:
The Board approved transfer of registration of Physiotens Tablet from M/s.
Highnoon to M/s. Abbott Laboratories (Pakistan) Ltd. Karachi alongwith the
change in manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof
Pharma GmbH, Germany, while the packaging site of the finished products will be
M/s. Abbott Healthcare SAS, France. The Board advised to provide site master file
of both sites and panel will inspect the manufacturing sites as well to comply the
provisions of import policy. The Board authorized its chairman to accord approval
for issuance of letter after compliance of aforementioned provisions.

Case No:08. Change of Manufacturing Site of Clozaril Tablets.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the
change of manufacturing site of their following registered imported drugs from M/s.
Novartis Pharmaceuticals, Horsham, Great Britain to M/s. Norartis Urunleri, Kurtkoy,
Istanbul, Turkey:-

S. No. Reg. No. Name of Drug (s).

1. 016329 Clozaril Tablets 25mg.
2. 016330 Clozaril Tablets 100mg.

They have deposited required fee and submitted following supporting documents:-

i) Copy of registration letter.

ii) Original legalized GMP Certificate of new manufacturing site.
iii) Copy of evidence of approval of Clozaril Tablets by FDA.
iv) Copy of evidence of approval of Clozaril Tablets by EMEA.
v) Copy of GMP Certificate of new site issued by MHRA.
vi) Copy of NOC for CRF.

33
 vii) Original legalized GMP Certificate issued by Medicines and Healthcare
Products Regulatory Agency (MHRA), United Kingdom.
viii) Original legalized CPP issued by Ministry of Health, Republic of Turkey
as an evidence of approval in the country of origin.
ix) Copies of the acknowledgement of last renewal of registration of the
products.
x) Copy of transfer of registration from M/s. Sandoz (Pakistan) Limited,
Karachi to M/s. Novartis Pharma (Pakistan) Limited, Karachi.
M/s. Novartis Pharma (Pakistan) Limited, Karachi have further submitted that
they will be importing these products from M/s. Novartis Pharma Stein AG, Switzerland
till they receive products from new manufacturing site.

M/s. Novartis Pharma (Pakistan) Limited, Karachi was advised to provide

legalized / notarized documents for approval of the “Clozaril tablets” from EMA, US
FDA, Japan & WHO form the same source. In reply the firm has provided legalized
Certificate of Pharmaceutical Product (CPP) of Australia from Australian Government,
Department of Health and Ageing, Therapeutic Goods Administration (TGA) as the proof
of approval of the “Clozaril tablets” manufactured by to M/s. Norartis Urunleri, Kurtkoy,
Istanbul, Turkey.

Decision:
Registration Board approved change in manufacturing site of Clozaril
Tablets from M/s. Novartis Pharmaceuticals, Horsham, Great Britain to M/s.
Norartis Urunleri, Kurtkoy, Istanbul, Turkey. However, the Board advised to
deposit remaining fee and provide site master file of manufacturing site. The Board
authorized its chairman to accord approval for issuance of letter after compliance of
aforementioned provisions.

Case No:09. Change of Manufacturing Site of Eloxatin Injetcion.

M/s. Sanofi-Aventis Pakistan Limited, Karachi have requested to approve the

change of manufacturing site of their following registered imported drugs from M/s.
Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi-
Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany
:-
S. No. Reg. No. Name of Products.
1. 044890 Eloxatin 50mg/10ml Concentrate for
Solution for Infusion.

34
 Each ml contains:-
Oxaliplatin …………… 5mg.

2. 044891 Eloxatin 100mg/20ml Concentrate for

Solution for Infusion.
Each ml contains:-
Oxaliplatin …………… 5mg.

They have deposited required fee and submitted following supporting

documents:-
i) Copies of Registration Documents.
ii) Original Legalized Certificate of Pharmaceutical Products.
iii) Original Legalized GMP Certificate.
iv) Original Legalized Manufacturing Authorization.

M/s. Sanofi-Aventis Pakistan Limited, Karachi was advised to provide legalized /

notarized documents for approval of the “Eloxatin Injection” from EMA, US FDA, Japan
& WHO form the same source. In response the firm has submitted a letter addressed to
Director Registration, Drug Regulatory Authority of Pakistan, Islamabad regarding
confirmation of registration and approval “Eloxatin Injection” from M/s. Sanofi-Aventis
Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany.
Keeping in view the submitted documents request of the firm for change of
manufacturing site of the products from M/s. Aventis Pharma, Rainham Road South,
Dagenham, United Kingdom to M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse
50, D-65926 Frankfurt am Main, Germany is submitted for consideration of the Drug
Registration Board.
Decision:
The Board approved the change in manufacturing site of above products
from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to
M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am
Main, Germany. However, the Board advised to provide site master file of new
manufacturing site and authorized its chairman to accord approval for issuance of
letter after compliance of aforementioned provision.

35
 Registration-II

Case No.10 Permission for bulk import and local repacking – Telfast D tablets
(Reg. No: 023617).

Registration Board in its 215th meeting deferred request of M/s Aventis, Karachi
for extension in bulk import and local repacking of Telfast- D Tablet (Reg. No.023617)
for five years, for clarification from the firm for plan of local manufacturing of Telfast- D
Tablet. Last permission for extension for bulk import and local repacking of subject item
was granted by the Chairman, Registration Board for two years which is up to 29th
August, 2009. Firm submitted an undertaking to establish their own facilities for
manufacturing of Telfast-D Tablets within this period. Permission was subject to no
further extension in future. Later on firm submitted that Telfast-D Tablet is manufactured
at Sanofi-aventis Pharmaceuticals Inc. USA and involves sophisticated unique
technology that enables slow release of pseudoephedrine using a tan-wax matric in these
bi-layered tablets. This also follows strict analytical procedures and quality tests to
maintain specification standards and safety precautions to be taken during its
manufacturing and analysis. Due to these facts, this site is responsible for supply bulk
tablet to all sanofi-aventis subsidiaries across the world to be imported in bulk followed
by local repacking at local units.
The Registration Board in its 223rd meeting discussed the case and advised firm to
transfer technology as committed previously and must develop facility for manufacturing
of Telfast-D Tablet. If firm is still interested for import, then they should brief the
Registration Board.

In the Registration Board’s 224th meeting dated 21st & 22nd April, 2010
Mr.Muhammad Amjad, Director Technical, Sanofi Aventis appeared before the board
and presented that Telfast-D Tablet cannot be manufactured in Pakistan due to low sale
volume and safety concern in manufacturing of fexofenadine and pseudoephedrine
combination. The board considered firm’s view about safety concern in manufacturing of
fexofenadine and discussed that firm is presently manufacturing fexofenadine tablets and
firm has already taken safety measures in its manufacturing. However in order to avoid
scarcity of product in market, it was decided to extended bulk import and local repacking
permission of Telfast- D Tablet (Reg. No.023617). Permission was valid till August

36
2011. The board also advised firm to transfer technology as committed previously and
must develop facility for manufacturing of Telfast-D Tablet. No further extension will be
granted after this permission. The Board after detailed discussion deferred the case for
personal hearing in next Registration Board.

Now firm has requested for further extension in the permission for bulk import
and local repacking of Telfast-D Tablets and have deposited fee amounting to
Rs.100,000/- for the purpose.

Decision:
Mr.Muhammad Idress incharge QA and Mr.Jaffar Zaida, Regulatory Officer, SITE
appeared before the Board and presented that initially M/s Sanofi Aventis, Karachi
was granted registration for finished import from M/s Sanofi Aventis, Kansas, USA
and later on permitted for bulk import and local repacking at their manufacturing
site. As per directions of Registration Board they have tried to make arrangements
for local manufacturing of the product but their principal did not agree to the
proposal as M/s Sanofi Aventis, Arkansas, USA is the only site of M/s Sanofi Aventis
for providing Telfast-D tablets across the globe.

Registration Board discussed and decided to permit M/s Sanofi Aventis, Karachi for
import of Telfast-D tablet from M/s Sanofi Aventis, Kansas, USA in tablet form and
then further processing to finished form in M/s Sanofi-Aventis, Karachi for 02 years
time. However, the Board advised firm to provide legalized COPP of the source and
authorized its chairman to accord approval for issuance of regsirtation letter.The
Board further advised the firm to apprise them about future strategy for transfer of
technology to Pakistan in 02 months time.

Case No:11: Use of packaging materials with old address.

M/s Novartis Pharma (Pakistan) Ltd, West Wharf, Karachi was granted
permission for bulk import and local repacking of their Amoxi-Clav range of products at
M/s CSH Pharmaceuticals, Lahore. They have now informed that they have imported
bulk stocks with repackaging address of 15, West Wharf Road, Karachi instead of CSH
Pharmaceuticals, Lahore due to error which was caused to due to some misunderstanding.
S. Reg. No. Name of drug(s) Quantity Value in

37
No. rupees
1. 031354 Amoxi-Clav Injection 1.2gm 980,273 116,652,463
2. 031355 Amoxi-Clav 375mg Tablet 743,492 52,044,426
3. 031356 Amoxi-Clav 625mg Tablet 2,554,843 196,722,880
4. 031357 Amoxi-Clav 1gm Tablet 417,131 43,798,734
5. 031353 Amoxi-Clav Injection 600mg 72,000 6,847,920
6. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension 732,132 51,351,738
60ml
7. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension 69,048 6,503,631
100ml
8. 031359 Amoxi-Clav 312.5mg/5ml Dry Suspension 921,024 83,500,036
60ml
9. 031359 Amoxi-Clav 312.5mg/5ml Dry 90,000 12,136,500
Suspension100ml
Total 6,579,942 569,558,329

Firm has requested that they may be allowed to repack the above mentioned
quantities at M/s CSH Pharmaceuticals; Lahore mentioning the address of M/s Novartis
Pharma (Pakistan) Ltd, 15, West Wharf Road, Karachi and bulk manufacturer address
will remain same i.e Sandoz Kundl, Austria.
Decision: Dr.Farid Khan, representative Pharma Beauru presented samples of
Amoxi-Clav 375mg Tablet onwhich old address has been blocked but new address
was yet to print. The Board discussed the matter in detail and advised the firm to
present samples of all drugs with blocked old address and printed new address for
its consideration.

Case No.12 Deferred Drugs.

a. M/s Healthtek Pharma, Karachi – 2SUM 500mg Injection

Registration Board in 237th meeting deferred following application of M/s
Healthtek Pharma, Karachi
Name of drug(s) & Proposed Demanded Date of Decision
Composition Pack size Price application,
Diary No.
& Form
2SUM 500mg Injection As per As per PRC 07-09-2012 Deferred for
Each vial contains: PRC 1551 submission of
Cefoperazone as sodium Form-5 application on
……………...250 mg Rs.8000/- form5D with

38
Sulbactam as sodium Rs.52,000/- balance fee
……………..250 mg 27-1-2013

Later on scrutiny of record reveals that this formulation is already registered in favour of
M/s Global Pharma, Islamabad under brand name of Toxibid Injection, Reg. No.049233.
Decision: The Board approved above product for registration for M/s Healthtek
Pharma, Karachi
b. Pharmatec Pakistan (Pvt.) Ltd, Karachi
Following product of M/s Pharmatec Pakistan, Karachi was deferred in 237th meeting
for review the case after submission of balance fee, GMP of source, COA and stability
data by the Expert Committee of Registration Board.

Name of Drug & Composition Pack size Demanded

MRP
Prazol 40mg Capsule 14’s As per PRC
Each capsule contains:
Omeprazole……………..40 mg
(Anti peptic ulcerants)

Now the firm has requisite information as under:-

i) Omeprazole Pellets will be purchased from M/s Vision Pharma, Islamabad
ii) GMP Certificate of M/s Vision Pharma, Islamabad
iii) Certificate of Analysis
iv) Stability data (for Zone IV. Both accelerated i.e 400C / 75% RH and long
term studies i.e 300C / 65% RH)

Decision: The Board approved above product for registration for M/s
Pharmatec Pakistan, Karachi.

c. M/s OBS Pakistan, Karachi

The Registration Board in 237th meeting deferred following application of M/s
OBS Pakistan, Karachi
Name of drug(s) & Proposed Demanded Date of Decision
Composition Pack size Price application,
Diary No. &
Form
C-Yalta 20mg Capsules 10’s Rs. 400.00 14-12-2010 The Sub Committee

39
 Each capsule contains:- Dy.No.2168 decided to review the
Duloxetine HCL……….20 Form-5 cases after
mg Rs.8000/- submission of
(Antidepressants) Rs.52,000/- balance fee, GMP of
06-2-2013 source of pellets,
COA and stability
data
C-Yalta 60mg Capsules 10’s Rs. 1200.00 14-12-2010 -do-
Each capsule contains:- Dy.No.2170
Duloxetine HCL……….60 Form-5
mg Rs.8000/-
(Antidepressants) Rs.52,000/-
06-2-2013
C-Yalta 30mg Capsules 10’s Rs. 600.00 14-12-2010 -do-
Each capsule contains:- Dy.No.2173
Duloxetine Form-5
HCL………..30 mg Rs.8000/-
(Antidepressants) Rs.52,000/-
06-2-2013

M/s OBS Pakistan, Karachi has now furnished the following documents:-
i) GMP Certificate of API source M/s Spansules Formulation, India

ii) Certificate of Analysis

iii) Stability study data on accelerated and real time study of API

iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decision: The Board approved above product for registration for M/s OBS
Pakistan, Karachi.

d. Correction cases:
i. M/s Sami Pharmaceuticals (Pvt.) Ltd, Karachi

M/s Sami Pharma, Karachi has requested for change of drug profile from plain to
extended release formulation for their already registered drug i.e ITP 150mg Tablet, Reg.
No.075852 containing Itopride HCl ….150mg. Firm has submitted that as the innovator
M/s Abbott Lab’s product Ganaton OD is available as extended release tablet, hence they
would like to market their product as extended release tablet. Firm has furnished
following document / information to support their request:-

i) Form-5
ii) Comparative study of Dissolution profile with innovator

40
 iii) Method of analysis
iv) Stability summary
v) Fee Rs.20,000/- for the purpose.
Decision: The Board discussed firms’s request and reviewed documents
submitted by the firm and then approved their request for change of drug profile
from plain to extended release formulation for their already registered drug i.e ITP
150mg Tablet, Reg. No.075852 containing Itopride HCl 150mg.

ii. Pharmatec Pharmaceuticals, Karachi.

The Registration Board in 236th meeting approved the following registration of

M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi and accordingly registration letter was
issued. Now the firm has pointed out some typographical mistakes in the said registration
letter. Details are as under:-
S. Existing Name & Composition Reg. No. Correct name & Composition
No.
1 Fenzitec Depot Injection 073773 Fenzitec Depot Injection
Each ml contains:- Each ml contains:-
Fluphenazine Decanoate …25mg Fluphenazine Decanoate …25mg
(Manufacturer’s Specification) (Manufacturer’s Specification)
Pack Size : 1mlx1’s
Pack Size : 5’s x1ml MRP : Rs.100.00
MRP : Rs.215.00 Pack Size : 1mlx10’s
MRP : Rs.1000.00

Firm has stated that they have applied aforementioned product with demanded
pack and MRP as mentioned in last column, as evidence firm has furnished Form-5. Firm
has requested for issuance of correction letter.
Decision: The Board agreed to the firm’s request and referred matter to Drug
Pricing Committee for fixation of MRP of Fluphenazine Decanoate …25mg/ml in
pack sizes of 1’s and 10’s.

41
 Registration-III
Case No.13 M/s Saibins Pharmaceuticals, Islamabad

The Registration Board in its 237th meeting referred the following product of M/s
Saibins Pharmaceuticals, Islamabad to a Committee comprising of following members.
The Board further decided that the recommendations of committee will be submitted to
the Chairman, Registration Board for decision & Ten (10) products per section policy
will be followed for new License / Section in accordance with the priority as given by the
firm:-

1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-
S. Brand Name / Label Demande Demanded Date of Previous
No. Claim d Pack Price Submission Decision
Size M-237
1. Muscide 4mg Capsules 10’s As Per 21-01-2013 Deferred
Each capsule contains:- Dy.No.996 for
Thicolchicoside ……4mg SRO Fee confirmation
(Anti-rheumatics (anti- Rs.20,000 of registration
inflammatory agents). status in
international
and national
market.

Now, the firm has submitted information that the above formulation is registered in
Grece, France, Italy, Poland, Portugal, Turkey & India. The applicant has also provided
the evidence of registration of above formulation in Pakistan of M/s Searle with brand
name Muscoril 4mg Cap & Inj. Other locally registered brands are Myoron (M/s
Angelini) & Thiolax (M/s SJ & G Fazul Ellahi). They have therefore requested to register
above formulation in their name.
Decision: The Registration Board after thorough deliberation decided to refer the
case to the review committee for review of formulation.

42
Case No.14: M/s Winilton Pharmaceuticals (Pvt) Ltd, Rawat

The Registration Board in its 237th meeting referred the following products of M/s
Winilton Pharmaceuticals (Pvt) Ltd, Rawat to a Committee comprising of following
members. The Board further decided that the recommendations of committee will be
submitted to the Chairman, Registration Board for decision & Ten (10) products per
section policy will be followed for new License / Section in accordance with the priority
as given by the firm:-
1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-

S. Brand Name / Label Demande Demanded Previous Decision

No. Claim d Pack Price M-237
Size
2. Kastwin 10mg Dispersible 14’s As Per SRO Deferred
Tabs. Fee for confirmation of
Each Dispersible tablet Rs.60,000 me-too status.
contains:-
Montelukast ………… 10mg
(Respiratory System)
3. Fenacwin 75mg Dispersible 2x10’s As Per SRO Deferred
Tabs. for confirmation of
Each Dispersible tablet Fee me-too status.
contains:- Rs.60,000
Diclofenac
Potassium…..75mg
(Anti-Rheumatics, Systemic)

Now the firm has clarified that due to typographical mistake the products at Sl.No.2 & 3
have been applied as dispersible while in actual fact the dosage form of product at
Sl.No.2 is chewable tablets and for product at sl.No.3 is plain tablets instead of
dispersible tablet. The firm has therefore, requested for issuance of registration of above
product in chewable dosage form for Sl.No.2 and in Plain Tablets for Sl.No.3.

43
Decision: The Registration Board deferred the above applications for
submission of complete registration dossier on Form-5 with clarification of dosage
forms of drugs.

Case No.15. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

The Registration Board in its 237th meeting referred the following product of M/s
Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi to a Committee comprising of following
members. The Board further decided that the recommendations of committee will be
submitted to the Chairman, Registration Board for decision & Ten (10) products per
section policy will be followed for new License / Section in accordance with the priority
as given by the firm:-

1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-
S. Brand Name / Label Demande Demande Date of Previous
No. Claim d Pack d Price Submission Decision
Size M-237

4. Mark Injection 1’s As Per 19-12-2011 Deferred

Each ampoule (5ml) SRO for confirmation
contains:- Fee of formulation
Zoledronic Acid as Rs.60,000 whether it is Dry
Monohydrate………..4mg Powder or
(Bisphosphonic Acid) Liquid
Ampoule.

The firm actually applied in Liquid Ampoule. Due to this reason the committee
recommended to defer the request of firm for confirmation of dosage form. Now the firm
has clarified that due to typographic error they applied in ampoule dosage form. But
actually dosage form / presentation of the formulation is Vial. The firm has therefore
requested to issue the registration of above product in Vial.

44
Decision: The Registration Board deferred the above registration application for
product specific inspection for verification of manufacturing and quality control
facility and the data / information submitted in the registration dossier by A.Q.
Javed Iqbal (Member, Registration Board) and Director DTL, Peshawar and area
FID.

Case No.16. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

The Registration Board in its 223rd meeting deferred the following products firm M/s
Trison Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column
as below:-
S. Brand Name / Label Claim Demande Demanded Previous Decision
No. d Pack Price M-223
Size
1 Triphenamol Tablets 100’s Rs.350.00 Deferred
Each tablet contains:- Fee Rs.20,000
Orphenadrine Citrate………35mg
Paracetamol………..450mg
(Manufacturer Specifications)
2 Tricidol Tablets 0.5mcg 10’s Rs.145.00 Deferred
Each film coated tablet contains:- Fee Rs.20,000
Alfacalcidol BP…………0.5mcg
(USP Specifications)
3 Trivelox 400mg Tablets 5’s Rs.460.00 Deferred
Each film coated tablet contains:- Fee Rs.20,000
Moxifloxacin (as HCl)……400mg

4 Trigesic 550mg Tablets 20’s Rs.180.00 Deferred

Each film coated tablet contains:- Fee Rs.20,000
Naproxen Sodium……….550mg
(Manufacturer Specifications)
5 Trinolol Tablets 50mg 20’s Rs.110.00 Deferred
Each film coated tablet contains:- Fee Rs.20,000
Atenolol USP……….50mg
(USP Specifications)
6 Tribastin Tablets 10mg 10’s Rs.100.00 Deferred
Each film coated tablet contains:- Fee Rs.20,000
Esbastine BP………….10mg
7 Trizadine Tablets 2mg 10’s Rs.102.00 Deferred
Each film coated tablet contains:- Fee Rs.20,000
Tizanidine (as HCl) …………2mg
(USP Specifications)

Now the firm has submitted that in 2010 the Registration Board in its 223rd meeting
granted five products per section to the new licensees and deferred the remaining product

45
as per policy. Now three years have passed it is therefore requested to grant the
registration above remaining product in their name. The firm has submitted an inspection
report dated 11-01-2011 which verifies the GMP status bearing the words “Firm was
GMP compliant at the time of inspection”.
Decision: The Registration Board deferred the above registration applications for
the evaluation of the registration dossiers. For Alfacalcidol tablet, product specific
inspection will be carried out by Director DTL, Lahore and area FID for
confirmation of manufacturing and quality control facilities.

Case No.17. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

The Registration Board in its 226th meeting deferred the following products of M/s Trison
Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column as
below:-
S. Brand Name / Label Claim Demanded Demanded Previous Decision
No. Pack Size Price M-226
1 Gerdnil 40mg Capsule 14’s Rs.300.00 Deferred for toll
Each capsule contains:- Fee Policy
Esomeprazole as Magnesium Rs.20,000
enteric coated (Pellets) Eq. to
Esomeprazole……..40mg
(Product Complies to
Manufacturer Specifications)
2 Prelin 75mg Capsules 14’s Rs.800.00 Deferred for toll
Each capsule contains:- Fee Policy
Pregabalin……..75mg Rs.20,000
3 Prelin 150mg Capsules 14’s Rs.1200.00 Deferred for toll
Each capsule contains:- Fee Policy
Pregabalin………….150mg Rs.20,000
(Manufacturer Specifications)
4 Azotri Capsule 6’s Rs.500.00 Deferred for toll
Each capsule contains:- Fee Policy
Azithromycin (as Rs.20,000
diyhydrate)…..250mg
(Manufacturer Specifications)
5 Omegab 20mg Capsule 14’s Rs.475.00 Deferred for toll
Each capsule contains:- Fee Policy
Omeprazole as enteric Rs.20,000
coated Pellets.……20mg
(Manufacturer Specifications)

46
 6 Trigab 100mg Capsules 10’s Rs.85.00 Deferred for toll
Each capsule contains:- Fee Policy
Gabapentin USP…….100mg Rs.20,000
(Manufacturer Specifications)
7 Trigab 300mg Capsules 10’s Rs.220.00 Deferred for toll
Each capsule contains:- Fee Policy
Gabapentin USP…….300mg Rs.20,000
(Manufacturer Specifications)
8 Hematose –F Syrup 60ml Rs.80.00 Deferred for toll
Each 5ml contains:- Fee Policy
Iron (III) Hydroxide Rs.20,000
Polymaltose Complex Eq. to
Elemental
Iron………………….50mg
Folic Acid BP….….0.43mg

Now, the firm has informed that they have developed their own facility of Capsule
(General) and Dry Powder Suspension (General) sections. The firm has therefore
requested that the above mentioned products which were initially applied on contract
manufacturing may please be registered in their own name. For product at S.No19 (Iron
Polymaltose Syrup) the firm has clarified that the dosage form is Dry Powder
Suspension. In support of this, the firm has stated that they have already been granted
Registration of Iron Polymaltose formulation plain in Dry Powder Suspension
Reg.No.063300 (Brand name Trifer). The firm also provided the reference of already
registered same formulations in Dry Suspension of following firms:
1. M/s Pharmedic (Brand Biofer Suspension).
2. M/s Trison Labs. (Brand Trifer Suspension)

Decision: The Registration Board deferred the above registration applications for
the evaluation of the registration dossiers.

Case No.18. M/s Medley Pharmaceuticals Wah Cantt

The Registration Board in its 234th meeting approved the following products of M/s
Medley Pharmaceuticals Wah Cantt in the same strength i.e. 20mg.
S.No Name and Composition of Pack Demanded Previous
. Product size Price Decision
M-234

47
 1 Esowel Capsules 20mg 2x7’s As Per SRO Approved
Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)

2 Esowel Capsules 20mg 2x7’s As Per SRO Approved

Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)

At the time of issuing registration letter, the firm pointed out that, they actually applied
the above products with two different strengths as under:-

S.No Name and Composition of Pack Demanded Decision

. Product size Price
1 Esowel Capsules 20mg 2x7’s As Per SRO Approved
Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)

2 Esowel Capsules 40mg 2x7’s As Per SRO Approved

Each Capsule Contains:
Esomeprazole (Pellets)….40mg
(Antipeptic Ulcerant)

The firm has deposited the fee of Rs.20,000/= for each product. The request of firm has
been verified from the dossiers. Actually due to typographic mistake the same strength
has been return in the agenda of Registration Board meeting. The firm has therefore
requested to please issue the registration of above formulation in 40mg. The registration
of above formulation in 20mg has been already issued to firm.
Decision: The Registration Board has approved request of firm.

Case No. 19. M/s Kanel Pharma, Gujranwala.

Registration Board in its 236th meeting approved the following product of M/s Kanel
Pharma, Gujranwala. The decision of the Registration Board is mentioned in last column
as under:-

S.No Name and Composition of Pack Demanded Previous

48
 . Product size Price Decision
M-236
1 Paroxin 12.5mg Capsules 30’s As Per SRO Approved
Each capsule contains:- subject to
Paroxetine as HCl ………… Fee compliance of
12.5mg Rs.20,000/= following:-
(Antidepressant) 1. GMP
Certificate of
Source.
2. COA
Certificate of
Analysis.
3. Stability
studies.

At the time of issuance of Registration letter, the firm informed that Paroxetine is not
available in Pellets or / Capsules dosage form & they actually, applied erroneously for
capsule dosage form. The firm has now requested to please change/correct the dosage
form as tablet. The firm has deposited Rs.5000/= in support of their request previously
the applicant had deposited Rs.15000/= for above product in capsule dosage form, at the
time of application before meeting of Registration Board. The firm has also requested to
adjust their already deposited fee of Rs.15,000/= for the instant request.
Decision: Registration Board has approved request of firm.

Case No.20. M/s Miracle Pharmaceuticals (Pvt) Ltd, Rawat

Registration Board in its 235th meeting deferred the following products of M/s Miracle
Pharmaceuticals (Pvt) Ltd, Rawat, with the conditions as mentioned in the second last
column against each product as under:-
S.N Name and Composition of Previous Information
o. Product Decision submitted by the
M-235 firm.
1 Clomin Tablets Deferred for The firm has submitted
Each film coated tablet contains:- rectification of that:
following 1. They will use methanol
Clomiphene Citrate …… 50mg observation in the as coating material instead
(Antioestrogen) dossier in the of Methylene chloride.
dossier:-
1. Methyline
Chloride should be
replaced with some
other suitable film
coating material

49
 2 Dimet DS Tablets Deferred for The firm has submitted
Each film coated tablet contains:- rectification of that:
following 1. They will use methanol
Diloxanide Furoate observation in the as coating material instead
(USP)..500mg dossier in the o Methylene chloride.
Metronidazole (USP)…… dossier:- 2. Dissolution test has
400mg 1. Methyline been submitted by the
(Nitroimidazole, Amoebicide) Chloride should be firm alongwith finished
replaced with some specifications of products.
other suitable film
coating material
2. Dissolution test
is absent in finished
product
specification.

3 Marither Forte Deferred for The firm has submitted

Each tablet contains:- rectification of that:-
following 1. Dissolution test has
Artemether ……… 80mg observation in the been submitted by the
Lumefantrin ……. 480mg dossier:- firm alongwith finished
(Synthetic Anti-Malarial derived 1. Dissolution test specifications of product.
from Artemisinin synthetic is absent in finished
Recemic Flourene Mixture) product
specification.

4 Irovit Capsules Deferred for -do-

Each capsule contains:- rectification of
following
Iron III hydroxide polymaltose observation in the
complex eq. to Elemental dossier:-
Iron……………. 100mg 1. Dissolution test
Folic Acid ……. 0.35mg is absent in finished
(Haematinic) product
specification.

Now the firm has fulfilled all the formalities as per decision of Registration Board. The
firm therefore requested to grant the registration of above in their name.

Decision: Registration Board after thorough deliberation approved products at Sl.

No.2 (Diloxanide Furoate + Metronidazole) & 3 (Artemether + Lumefantrin). While
the products at Sl.No.1 & 4 have been deferred by the Registration Board for
product specific inspection for confirmation of manufacturing and quality control
facilities by A.Q. Javed Iqbal (Member, Registration Board) and Director, DTL,
Peshawar and area FID. Brand name of product at S.No.1 will be changed.

50
Case No.21. M/s Global Pharmaceutical, Islamabad

Registration Board in its 229th meeting approved the following product of M/s Global
Pharmaceutical, Islamabad. The decision of the Registration Board is mentioned in last
column as under:-

S.No. Name and Composition of Pack size Demanded Previous

Product Price Decision
M-229
5. Tamsol-D Tablets 10’s As Per SRO Approved
Each film coated tablet Fee
contains:- Rs.8,000/=
Tamsulosin Hydrochloride
…0.4mg
(as modified – release tablets)
Dutasteride………………0.5mg

Accordingly the Registration was granted to the firm on 11th September, 2012. Later on,
it was identified that the above formulation does not exist in tablet dosage form
internationally or locally. However, it is available in capsule dosage form. The case is
submitted for reconsideration of formulation by the Registration Board.
Decision: Registration Board after considering the technical opinion by its members
decided to ask the manufacturer to appear before Registration Board for
presentation of his opinion regarding efficacy of the above drug formulation. The
Board further ordered that till final decision, the registration of above product
would remain suspended under section 7(11) (ad) of Drug Act, 1976.

Case No.22. M/s Warafana Pharmaceutical, Islamabad.

Registration Board in its 235th & 237 meeting deferred the following products of M/s
Warafana Pharmaceutical, Islamabad. The decision of the Registration Board is
mentioned in last column as under:-

S.No. Name and Composition of Pack Demande Previous Decision

Product size d Price M-235th & 237th
1 Clari-250 Tablets 1x10’s As Per Deferred for
Each tablet contains:- SRO rectification of
following observation
Clarithromycin ……250mg

51
 (Macrolide Antibiotic) Fee in the dossier:-
Rs.8000 1. Methylene
Choloride should be
replaced with some
Balance other suitable film
fee coating materal.
Rs.12000/
=
2 Fusifit-B Cream 1’s As Per Deferred
Each gm contains:- SRO for confirmation of
Fusidic Acid ……..2.0% w/w Fee steroidal section
Betamethasone as Valerate Rs.60,000 and me-too status.
(BP)……………. 0.1% w/w
(Anti-Inflammatory & Anti-
Pruritic Effects).

3 Fusifit-H Cream 1’s As Per SRO -do-

Each gm contains:-
Fusidic Acid ……..…..20mg Fee
Hydrocortisone Acetate Rs.60,000
BP..10mg
(Anti-Inflammatory & Anti-
Pruritic Effects).

Now the firm has submitted that they have replaced Methylene Choloride with water base
film coated material FC 4-H for the product at Sl.No.30 (Clarithromycin 250mg Tablet).
For the products at Sl.No.31&32 the firm has submitted the proof / approval of steroidal
section for cream. The firm has requested for issuance of registration of above products.

Decision: The Registration Board has approved request of firm.

52
 Registration-IV

Case No. 23. M/s. Saaaf Pharmaceuticals, Risalpur

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the
following products of M/s. Saaaf Pharmaceuticals, Risalpur for rectification of
shortcoming of the following products.-

S.N Name of
Pack Demande
o manufactu Name of drugs (s) Decision
size d MRP
rer
1. Deferred for
P.S.I & GMP
Varisaf Tablets 229th Meeting
M/s. Saaaf Each tablet contains:- 22.1.2011.
As Per
Pharmaceutica Mebeverine 3x10’s Fee paid,
SRO
ls, Risalpur HCl……200 mg confirmation of
(Antispasmodic) formulation.
237th 26.02.2013

2. Deferred for
P.S.I & GMP
XL Tablets
229th Meeting
Each film coated tablet
22.1.2011.
contains:- As Per
-do- 10’s Fee paid,
Linezolid……..600 SRO
confirmation of
mg
formulation.
(Antibiotic)
237th 26.02.2013

3. Deferred for
XL Dry Powder P.S.I & GMP
Suspension 229th Meeting
Each 5 ml contains:- 22.1.2011.
As Per
-do- Linezolid ……..100 60 ml Fee paid,
SRO
mg confirmation of
(Antibiotic) formulation.
237th 26.02.2013

The firm paid the differential fee. The management could not rectify the relevant
shortcomings in comparison of the brand leader (Mebeverine HCl 200mg/ Colofac Cap of
Abbott Lab); Linezolid Film coated tablet: Incorrect M.O.T. and dissolution profile not
submitted; Linezolid Dry Powder Suspension M.O.T. incorrect, Master formulation is

53
ambiguous. The management requested to grant the registration of above mentioned
products.

Decsion: Registration Board decided to conduct product specific inspection by

Director DTL, DDG (E&M) and ADC, Peshawar, Peshawar for above products.
Moreover, firm will be advised to complete registration applications.

Case No. 24. Deferred Drug

The Drugs Registration Board in its 237th meeting held on 26th February, 2013 had been
deferred the following application due to shortcomings in application dossiers:-

S.No. Name of Firms Name of Drugs /label AU Price Date Remarks

Claim
1. M/s. Novae Xiben 200 mg Capsule 10’s As 25- SDS > FDA limit
Pharmaceuticals, Each capsule contains:- 20’s Per 1- To be deferred
Hattar Celecoxib…….200 mg SRO 2013
General Tablets (NSAID)
General
Capsules
Dry Powder
Suspension
General
2. -do- Macrozith 250 mg 6’s As -do- Principally Film Coated
Capsule 10’s Per Tablet
Each capsule contains:- SRO Master Formulation does
Azithromycin dihydrate not conform with film
≡ Azithromycin ……250 coated tablet
mg Uniform decision is
(Macrolide) required about existing
dosage form of Capsule
Azithromycin

3. -do- Voxipro 250 mg Dry 60 ml As -do- Master formulation

Powder Suspension Per MOP
Each 5 ml contains:- SRO Inconformity
Ciprofloxacin MOT
Hydrochloride To be deferred.
≡ Ciprofloxacin …..250
mg
(Quinolone) (Mfg Spec)

54
4. -do Arthen Dry Powder 30 ml As -do- SDS > FDA limit
Suspension 60 ml Per To be deferred
Each 5 ml contains:- SRO
Artemether……..15 mg
Lumefantrine…..90 mg
(Antimalarial)

5. -do- Leoflox 125 mg Dry 60 ml As -do- Label claim

Powder Suspension Per MOT’
Each 5 ml contains:- SRO Incorrect
Levofloxacin To deferred.
hemihydrates
≡ Levofloxacin
………..125 mg
(Quinolone)

6. -do- Zason 10 mg Dry Powder 60 ml As -do- Master formulation

Suspension Per ambiguous /incorrect.
Each 5 ml contains:- SRO Deferred for
Zinc Sulphate
monohydrate
≡ Zinc (element)………10
mg
(Antidiarrhoeal & Zinc
Supplement)
7. -do- Bevexin 20 mg Tablets 2x10’s As -do- Master formulation
Each tablet contains:- Per MOT +Specification
Piroxicam β-Cyclodextrin. SRO Deferred.
≡ Piroxicam………….20
mg
(NSAID)
8. -do- Leoflox Tablets 250 mg 1x10’s As -do- Film coated
Each film coated tablet Per Wrong label claim
contains:- SRO Wrong specification.
Levofloxacin Hemihydrate Incorrect DIT
≡ Levofloxacin ……..250 Chromatographic
mg condition not mentioned
(Quinolone) Deferred for
9. -do- Leoflox Tablets 500 mg 1x10’s As -do- Incorrect Specification
Each film coated tablet Per Incorrect MOP/MOT
contains:- SRO Signature of QCM/PM
Levofloxacin Hemihydrate Deferred.
≡
Levofloxacin…………500
mg
(Quinolone)

55
10. -do- Voxipro 250 mg Tablets 10’s As -do- Specification
Each film coated tablet Per MOP
contains:- SRO MOT
Ciprofloxacin Master formulation
Hydrochloride To be deferred
≡ Ciprofloxacin …….250
mg

11. -do- Voxipro 500 mg Tablets 10’s As -do- Incorrect

Each film coated tablet Per Specification/MOP/MOT
contains:- SRO Finished
Ciprofloxacin Signature of QCM/PM
Hydrochloride deferred
≡ Ciprofloxacin………
.500 mg
(Quinolone) (B.P.)

12. -do- Moxigrat 400 mg Tablets 1x5’s As -do- SDS is more than FDA
Each film coated tablet 1x10’s Per limits
contains:- SRO MOT/MOP
Moxifloxacin HCl Specification incorrect
Moxifloxacin ……….400 Deferred.
mg
(Quinolone)
13. -do- Arthen DS Tablets 1x8’s As -do- Master formulation
Each tablet contains:- Per Subject to correction
Artemether……..40 mg SRO for.
Lumefantrine…..240 mg
(Antimalarial)

14. -do- Montigrat Tablets 10 mg 14’s As -do- MOP coating procedure

Each film coated tablet 2x10’s Per is mentioned
contains:- SRO Coating material has not
Montelukast Sodium been mentioned
≡Montelukast …..….10 MOT is not correct.
mg To be deferred.
(Leukotriene Receptor
Antagonist)

15. -do- Novaefen 100 mg Tablets 3X10’S As -do- Product Specification

Each film coated tablet Per MOP/MOT do not
contains:- SRO conform
Flurbiprofen....100 mg To be deferred.
(NSAID)

56
 16. -do- Painclay 75 mg Tablets 1x10’s As -do- Spec/MOT/MOP are
Each enteric coated tablet 2x10’s Per contradicting
contains:- 3x10’s SRO To be deferred.
Diclofenac Potassium…75
mg
(NSAID)
17. -do- Painclay 100 mg Tablets 1x10’s As -do- Spec/MOT/MOP are
Each enteric coated tablet 2x10’s Per contradicting
contains:- 3x10’s SRO To be deferred.
Diclofenac Potassium..100
mg
(NSAID)

Now the firm has rectified shortcomings upto S.No.16. But the master formulations
(S.No. 17) of tablet Diclofenac potassium does100mg not conform with the
internationally available dosage forms.

Decision: Registration Board approved products at S.No.1-16 while product at

S.No.17 deferred for confirmation of international availability.

Case No. 25. M/s. Hizat Pharmaceuticals, Peshawar

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the
following products for rectification of shortcoming:-

Submission
Esoprazol capsule
of differential
Each delayed release
fee
capsule contains:-
M/s. Hizat and
Esomeprazole enteric
Pharmaceuticals, 10’s Rs.159.00 confirmation
coated pellets
Peshawar of
≡Esomeprazole……...40
formulation.
mg
Pellet’s fee
(Proton Pump Inhibitor)
unpaid
Submission
Lanzprazole Capsule
of differential
Each Delayed Release
fee and
Capsule contains:-
confirmation
-do- Lansoprazole enteric coated 10’s Rs.160.00
of
pellets
formulation.
≡ Lansoprazole……30 mg
Pellet’s fee
(Proton Pump Inhibitor)
unpaid

57
 The firm had rectified relevant shortcoming and paid differential fee mentioning Vision
Pharmaceutical as the source of pellets of Esomeprazole (22.5% w/w) and Lansoprazole
(8.5% w/w) .The firm requested to grant the registration of above mentioned products.

Decision: Request of firm was approved by the Board.

Case No.26 Navegal Labs, Hattar

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the
following products of M/s. Navegal Labs Hattar for submission of complete method of
manufacturing and studies regarding dissolution/release of the following drug:-

S. Manufacturer Name of the Drug Pack Demanded Decision

No. size Price
Navegal Labs Movez SR Capsule 1x10 Rs.8.5/capsule. Deferred in
Hattar 100 mg. view of
Each Capsule strength and
Contains:- uniform
Diclofenac Sodium policy. Fee
Sustained Release/ paid
Coated Pellets
≡ Diclofenac
sodium…100 mg.

It is pointed out that sustained release coated pellets of Diclofenac Sodium 100mg are
manufactured by M/s. Vision Pharmaceuticals, Islamabad which can be approved subject
to submission of Specification of product, GMP, Certificate of Analysis and Stability data
for zone IV. Fee is paid according to local manufacturer.

Decision: Request of firm was approved with source of pellets will be M/s.
Vision Pharmaceuticals, Islamabad.

Case No. 27. M/s Alen Pharmaceutical (Pvt) Ltd, Risalpur.

Drug Registration Board in its 237th meeting had deferred the following products of M/s.
Alen Pharmaceuticals (Pvt.) Ltd; Risalpur subject to the confirmation of formulation.

S.No Manufacturer Name of Drugs A/Unit Price Remarks

58
 1. M/s Alen Mitex Tablets. 1’s Rs. Confirmation
Pharmaceutical Each film coated tablet 100.00 of
(Pvt) Ltd, contains:- formulation.
Risalpur Ivermectin BP………6 Total fee
mg. paid

The firm had rectified relevant shortcoming and paid differential fee. The firm had
requested to grant the registration of above mentioned products

Decision: Request of firm was approved by the Registration Board.

Case No.28 M/s. Aries Pharmaceuticals, Peshawar.

M/s. Aries Pharmaceuticals, Peshawar has requested for registration of the

following drugs:-

1. M/s. Aries Levocap Capsules 250 10’s Rs.260.00 - Fee paid,

Pharmaceuticals, mg do- deferred for
Peshawar Each capsule contains:- uniform
1.Tab General Levofloxacin decision.
2. Capsule Gen Hemihydrate
3.Tab Psycho ≡ Levofloxacin ….250
mg
(Quinolone)

2. -do- Levocap Capsules 500 10’s Rs.520.00 - Fee paid,

mg do- deferred for
Each capsule contains:- uniform
Levofloxacin decision.
Hemihydrate
≡ Levofloxacin ….500
mg
(Quinolone)

3. -do- Pranax 1 mg Tablets 3x10’s Rs.369.00 - As per policy

Each tablet contains:- do- on
Alprazolam…….1 mg psychotropic/
(Antidepressant) narcotics.
Fee paid.
Deferred.
4. -do- Pranax 2 mg Tablets 3x10’s Rs.738.00 - As per policy on
Each tablet contains:- do- psychotropic/
Alprazolam…….2 mg narcotics. Fee

59
 paid.
Deferred

These drugs were considered in 237th meeting of Registration Board decision mentioned
against each. Now the firm has stated that Pranax 0.5mg (Alprazolam0.5 mg) is already
registered with the firm where as Pranax 1 mg & 2 mg are the additional strengths of
Alprazolam which are requested to be registered.
Levofloxacin 250 mg/500 mg Capsules have been registered with many manufacturer
therefore the firm requested to approve registration of the Levofloxacin 250 mg/500 mg in
the form of Capsules. Levofloxacin in the form of Capsule (dosage form) has to be decided
uniformly.

Decision: The Board referred products at S.No.1 & 2 to review committee for
evaluation and recommendation. Products at S.No. 3 & 4 were deferred being
controlled drug.

Case No.29. M/s. Libra Pharma (Pvt.) Ltd; Peshawar

The Drug Registration Board in its 195th meeting had approved the following products of
M/s. Libra Pharma (Pvt.) Ltd; Peshawar subject to installation & verification of HVAC
system and segregated section. It is submitted that the ingredients and strength of some
products were typed incorrectly which were approved accordingly.

S.No Name of drug with Name of drug with Pack Demande Decision
incorrect formulation correct size d MRP
formulation/strength
1 Cryptosad Tablets Cryptosad Tablets 21’s Rs.240.0 Approved
Each tablet contains:- Each sugar coated 0 subject to
Cyproterone acetate tablet contains:- installatio
…...2mg Cyproterone acetate n and
Ethinyloestroadioe….35 …… 2 mg verificati
mg Ethinyloestradiol . on of
…..35 mcg HVAC
System
and
Segregate
d section.
2 U-Dine 100 mg Tablets U-Dine 100 mg 14’s Rs.1600. -do-
Each tablet contains:- Tablets 00

60
 Lamivudine……..100 Each film coated
mg tablet contains:-
(Anti-retroviral) Lamivudine……..10
0 mg
(Anti-retroviral)
3 Osteocol Oinetment Osteocol Ointment 1x10’ Rs.275.0 Approved
Each tablet contains:- Each gm contains:- s 0
Tacalcitol……….2mcg Tacalcitol
(Antipsoriasis / Vitamin monohydrate
≡ Tacalcitol.…. 2
mcg
4 Diploprate Cream Diploprate Cream 5gm Rs.21.20 Approved
Each gam contains:- Each gm contains:- subject to
Diflucortolone Diflucortolone installatio
valeate...0.001gm valerate.…1 mg n and
Chlorquinalolol..….0.01 Chlorquinaldol…… verificati
0gm …. 10 mg on of
HVAC
System
and
Segregate
d section

The firm has furnished copy of inspection report wherein FID, Peshawar has reported that
the firm has installed HVAC and has requested to grant the registration of above
mentioned product. The Licensing Section confirmed that the firm got approval of
Hormonal Tablets Section as segregated with HVAC but Hormonal Ointment/Cream
Section is not present in record of licensing unit.
The firm has deposited remaining fee amounting Rs. 12000/- for each formulation and
furnished copy of inspection report and has requested to grant the registration of above
mentioned products. It is worthwhile to mention that Tacalcitol monohydrate equivalent
to Tacalcitol is available in the form of Ointment/Lotion (Curatoderm Ointment/Lotion)
but the strength is 4 mcg/gm in both dosage form instead of 2 mcg/gm as mentioned in
the application dossier. .
Decision: Registration Board approved products at S.No.1 &2 and advised to
review the registration dossiers before issuance of registration letter and authorized
its Chairman to grant approval for issuance of registration letter. Products at S.No3
& 4 were deferred for confirmation of steroidal section for cream and ointment. As

61
 Tacalcitol is available only in 4 mcg/gm thus referred to review committee for
review.
Case No.30 Extension in contract manufacturing permissions.

The following drugs of M/s. Navegal Laboratories, Hattar for toll manufacturing
extension were left over due to oversight. The firm had deposited the Rs.8000/- each on
29th September, 2010 and remaining fee of Rs. 42000/- each on 9th April, 2013.

1. 045442 M/s. Toll Uneek 250mg Dy. Cephalospori

Navegal manufactured by Injection No.2873 n
Pharmaceuti M/s. Welmark Each vial contains:- Form-not
cals, Hattar Pharma, Hattar Ceftriaxone (as Rs.42000/-
Sodium)……..250mg Rs.8000/-
(USP Specification) dated 29-
09-2010
2. 053219 -do- -do- Uneek 500mg Dy. Cephalospori
Injection No.2873 n
Each vial contains:- Form-not
Ceftriaxone (as Rs.42000/-
Sodium)……..500mg Rs.8000/-
(USP Specification) dated 29-
09-2010
3. 045441 -do- -do- Uneek 1gm Injection Dy. Cephalospori
Each vial contains:- No.2873 n
Ceftriaxone (as Form-not
Sodium)……..1gm Rs.42000/-
(USP Specification) Rs.8000/-
dated 29-
09-2010
4. 045443 -do- -do- Sobeta 2gm Injection Dy. Cephalospori
Each vial contains:- No.2873 n
Cefoperazone (as Form-not
Sodium) ….....1gm Rs.42000/-
Sulbactam (as Rs.8000/-
Sodium)…1gm dated 29-
(USP Specification) 09-2010
5. 045444 -do- -do- Sobeta 1gm Injection Dy. Cephalospori
Each vial contains:- No.2873 n
Cefoperazone (as Form-not
Sodium) ….....0.5 gm Rs.42000/-
Sulbactam (as Rs.8000/-
Sodium)……..0.5 gm dated 29-
(USP Specification) 09-2010

62
6. 045438 -do- -do- Effo 500mg Injection Dy. Cephalospori
Each vial contains:- No.2873 n
Cefepime HCl with Form-not
L-arginine Rs.42000/-
≡Cefepime Rs.8000/-
…….500mg dated 29-
(USP Specification) 09-2010

Decision: Request for extension in contract manufacturing acceded till

30.06.2015.

Case No.31. M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar

M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar has applied for registration
of following drugs for the purpose on export only:-
S. No. Name of Drug(s) Remarks
1. Phenomed 30 mg Tablet The relevant documents and
Each tablet contains:- total fee received,
Phenobarbiton ……..……. 30 mg Approved subject to the concurrence of
Narcotic Control Department /Board.
2. Dipam 5 mg Tablet -do-
Each tablet contains:-
Diazepam …………….. 5 mg

The firm has submitted following documents:-

i. Application on Form-5.
ii. Fee of Rs. 20000/- for each formulation.

The firm possesses the relevant facility to manufacture the above mentioned
products. This case was discussed in the 237th meeting or Registration Board. The
decision of the Board is mentioned against each.
Decision: Committee on allocation of controlled Drug has already conveyed that
Registration Board may take decision according to its rules. Thus Board approved
firm’s request. Matter regarding allocation of quota will be dealt by Committee on
allocation of controlled Drug accordingly.

Case No.32. M/s. Shaheen Pharmaceuticals, Swat

63
The Drug Registration Board in its 235th meeting had deferred the following products of
M/s. Shaheen Pharmaceuticals, Swat subject for deletion of Methylene Chloride from the
formulation.

1. M/s. Shaheen Finas-M 1mg 3x10’ As -do- Deferred due to

Pharmaceutical Tablets s Per Methylene
s, Swat Each tablet SRO Chloride.
1. Tab General contains:-
2.Tab Antibiotic Finasteride
3.Cap General ………..1mg
4.Dry Powder (5-alpha reductase
Susp (Ceph) inhibitor)
2. -do- Paroxet 10mg 3x10’ As -do- Deferred due to
Tablets s Per Methylene
Each tablet SRO Chloride.
contains:-
Paroxetin (as
HCl).10mg
(Antidepressant)

3. -do- Paroxet Plus 20mg 3x10’ As -do- Deferred due to

Tablets s Per Methylene
Each tablet SRO Chloride.
contains:-
Paroxetin (as
HCl).20mg
(Antidepressant)

4. -do- Nomide 20mg 3x10’ As -do- Deferred due to

Tablets s Per Methylene
Each tablet SRO Chloride.
contains:-
Leflunomide……2
0mg
(Anti-rheumatic
systemic)

Now the firm has rectified the shortcoming of the formulation. The firm had
requested to grant them the registration of above mentioned products

Decision: Registration Board approved firm’s request.

Registration-V

64
Case No. 33. Transfer of Registration of contract manufacturer from Contract
Donor.

M/s Allmed (Private) Ltd. Lahore (Formerly M/s Ever Green Pharmaceuticals (Pvt.) Ltd.
Lahore) have requested for transfer of registration of following product manufactured by
them on contract basis for M/s. Ontech Corporation, B-154 Block-13-D/2 Gulshan-e-
Iqbal, Karachi to their name.
S. No. Reg. No. Name of Drug with
Composition
1. 041199 Norepine Injectable
Each 4ml contains:-
Noradrenaline tartarate…8mg

It is submitted that the product was initially registered for import in the name of M/s.
Ontech Corporation, Karachi for finished import. Later on the product was transferred
from import to local toll manufacturing by M/s Allmed (Private) Ltd. Lahore (formerly
M/s. Evergreen Lahore).
Registration Board in 237th meeting has already delegated the power of transfer of
registration from one manufacturer/importer to another manufacturer/importer to its
Chairman. However in this case the contract manufacturer is applying for transfer of
registration from contract giver. The firm has also applied for extension of contract
manufacturing for the said product and has submitted the following for transfer of
registration:-
1. Fee challan of Rs.20,000/-
2. Form-5
3. N.O.C on transfer from M/s Ontech Corporation, Karachi.
4. Import Registration letter in the name of M/s. Ontech Corporation, Karachi.
5. Copy of earlier toll permission letter.

Decision: Registration Board deferred the request of the firm for following:
Confirmation whether transfer of registration is permissible under
contract manufacturing policy or otherwise.
Verification of testing facility by Director DTL, Lahore and area FID.

Case No.34. M/s. Paradise Pharmaceuticals, Lahore

65
 M/s. Paradise Pharmaceuticals, Lahore was granted the registration of following
product:-
S. No. Name of Drug(s) Reg. No.
1. Ampride Syrup 071546
Each 5ml contains:-
Ammonium Chloride ……………… 100mg

The firm has requested that this product in not according to products being
marketed locally. They have therefore, requested to change the formulation as under:-
Ampride Syrup
Each 5ml contains:-
Chlorpeniramine Maleate ………..… 2mg
Ammonium Chloride ……………… 100mg
They have deposited fee of Rs. 20000/- for this purpose and furnished application
dossier on Form-5.
It is submitted that the firm has attached the outer packing of British Pharma
which contains Sodium Citrate also in addition of Chlorpeniramine Maleate 2mg &
Ammonium Chloride 100mg. However, according to the firm Sodium Citrate is not an
active ingredient and has been included in in-active ingredients. US FDA also mentioned
Sodium Citrate as inactive ingredient in syrup dosage form
Decision: The request of the firm was acceded to.
Case No. 35 M/s. Medipak Ltd; Lahore
The Drugs Registration Board in its 222nd meeting had deferred the following
product of M/s. Medipak Ltd; Lahore for review committee. Initially the case was
discussed in 141st meeting of the Drug Registration Board and was deferred for price
comparison and subsequently again deferred in 213th meeting of DRB for getting
clarification from the firm regarding the use of the formulation:-
Medisol Solution
Each liter contains:-
Citric acid (Anhydrous)............7.30gm
Sodium Citrate (Dihydrate)…22.00gm
Dextrose (Monohydrate).24.50gm
Water for Injection....Q.S
(Anticoagulant Solution)

66
The firm has informed that the pricing section has approved the price of the subject
product in 19th meeting of Price Recommendatory Committee held on 26-12-2006 and
has requested for grant of registration of above mentioned product. The firm has
deposited fee of Rs. 15000/- in addition to Rs.5000/- and has not submitted new form-5.

Decision: The Registration Board deferred the case for submission of new dossier,
applicable fee for the product and expert opinion by Brig. Qaiser, AFIC.

Case No. 36 M/s. CCL Pharma Lahore.

Following application of M/s. CCL Pharma Lahore was deferred in sub/expert committee
meeting 237th of Drug Registration Board due to inadequate fee for fast track and
different formulation from originator. The originator formulation is as following
(Duodart / Jalyn capsule by GSK):-
Each Capsule contains the following:

• One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of
dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of
caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric
oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium
dioxide.
• Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin
hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion,
microcrystalline cellulose, talc, and triethyl citrate.

S.No Name of the drugs with Pack Proposed Date of Recomme

composition Size Price Submission ndations of
Committe.
1. BPH Capsules 10’s As per 15-6-2011 Deferred.
Each capsule contains:- brand Fee.8000
Dutasteride….0.5mg leader Fast track
Tamsulosin….0.4mg fee
submission
Fee.52000
21-2-2013

The firm has submitted fee of Rs. 300,000/- and has submitted that competitor
formulation is immediate release dutasteride pellets in soft gel capsule filled in hard
gelatin capsule along with sustained release tamsulosin pellets, which has no technical

67
 advantage but a novelty. But in their formulation they are using a blend of immediate
release dutasteride pellets along with sustained release tamsulosin pellets filled in hard
gelating capsule. They have submitted 2 reference products of india Tamlocept D
Capsule by Lupin Ltd. (Pinnacle Pharmaceuticals, India) and Tamdura Capsule by Sun
Pharmaceutical industries Ltd. India. Containing Dutasteride IR + Tamsulosin SR pellets.
They have submitted comparative dissolution profile with Duodart capsules.
Decision: The Registration Board deferred the case for evaluation by the review
committee.

Case No. 37. Cases of 237th meeting Registration Board

Following applications (Fast track) were considered in 237th meeting and subsequently in
me-too committee on 08-03-2013 subject to differential fee. Now differential fee have
been paid for following applications.

S.No Name of Firm Name of the drugs with composition Pack Proposed Previous Remarks
Size Price Decision
1. M/s Saffron Noctis Capsule 14’s Rs 300/- Approved Rs.2,40,000/-
Pharmaceutica Each capsule contains:- subject to + Fee
ls Faisalabad Omeprazole…40mg Source deposited
GMP Rs.60,000/-
certificate, GMP
COA and certificate of
stability M/s
study of Metrochem
pellets. API Pvt. Ltd.,
India.,CoA,
2. M/s. English Terol 4mg SR Capsules 3×10’s Rs.2300/- Deferred for Detrusitol
Pharmacutical Each capsule contains:- confirmatio Capsule SR 4
s Industries, Tolterodine HCl equiv. to n of mg (Pfizer)
Lahore Tolterodine SR…4mg me-too Comparative
status and Dissolution
comparative profile with
dissolution originator.
profile with
originator
3. M/s. English Urimax 0.4 mg Capsule 3×10’s Rs.1100/- Approved Rs.240, 000/
Pharmacutical Each capsule contains:- subject to has been
s Industries, Tamsulosin HCl equiv to remaining deposited,

68
 Lahore Tamsulosin…0.4mg fee of GMP
(Alpha-1-adrenergic blocker) Rs.240, certificate of
000/ (in source, COA
case of and stability
import of studies of
pellets),GM pellets.
P certificate
of source,
COA and
stability
studies of
pellets.
4. M/s. English K-Cit Tablets 3×10’s Rs.650/- Deferred for Urocit K of
Pharmacutical Each tablet contains:- confirmatio Universal
s Industries, Potassium Citrate…10 mEq n of me-too (Allmed
Lahore status. Pharma)
5. M/s. English Dutride-T Capsules 30’s Rs. Deferred Fee submitted.
Pharmacutical Each capsule contains:- 2700/- Firm wants to
s Industries, Dutasteride …….0.5mg fill in pellets.
Lahore Tamsulosin
Hydrochloride….0.4mg
6. M/s. English Ucholin 10mg Tablet 60’s Rs.1500/- 06-02-2013 Deferred for
Pharmacutical Each tablet contains:- confirmation of
s Industries, Bethanechol Chloride equiv. to me-too status.
Lahore Bethanechol …..10mg

Decision: Registration Board decided as follows:

Approved products at S.No.1 and 3.
Product at S.No.2 deferred for verification of complete formulation with
originator (Detrusitol Capsule SR 4 mg by Pfizer) and Comparative
Dissolution profile with originator.
Product at S.No.4 deferred for Product Specific Inspection by Director DTL
Lahore, Director DTL, Quetta and Area FID.
Product at S.No.5. The firm has submitted a separate application for tablet
dosage form. The DRB deferred the case for evaluation by review committee.
Product at S.No.6 deferred for expert opinion by Gen.Dr. Tassawar Husain,
Dr. Falak Sher Bhatti, Nescom., Prof. Shoaib Shafi, RMC.

69
Case No. 38. M/s. Medipak Ltd; Lahore
The Drugs Registration Board in its 201st meeting had rejected the following
product of M/s. Medipak Ltd; Lahore as the cGMP condition of the section was not
good:-
Medisol ½+5% Infusion. 500ml As per Rejected as the
Each 1000ml contains:- Policy CGMP condition
Dextrose of the section is
Monohyrate……….55gm. not good.
Sodium Chloride….4.5gm.
(BP)

The firm submitted application in Drug Appellate Board and the Drug Appellate Board in
its 135th sitting held on 123-11-2008 decided and accepted the appeal to grant them the
registration of above mentioned product.
Decision: The Registration Board deferred case for product specific and GMP
inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;
DDG E&M, Lahore and Area FID.

Case No: 39 M/s. Medipak Ltd; Lahore

M/s Medipak Limited, Lahore has requested that their product “Moxidex Eye
Drops” was included in Agenda of 229th DRB meeting, but they said product was written
under the name of M/s Vega Pharma Lahore by mistake and the product was deferred for
GMP & Product specific Inspection.
They have submitted that their Eye Drop section is already approved and GMP inspection
report dated 11-02-10 submitted. They have submitted copy of registration dossier.
Decision: The Registration Board deferred case for product specific and GMP
inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;
DDG E&M, Lahore and Area FID..

Case No.40. M/s. Medisave Pharmaceuticals, Lahore.

M/s. Medisave Pharmaceuticals, Lahore has requested for registration of

following drugs for export purpose only:-

70
 S.No Name of the products with composition

1. Flusave Tablets
Each Tablet contains:-
Triprolidine HCl B.P……… 2.5mg
Pseudoephedrine HCl B.P …...60mg
2. Sorefix-P Tablets
Each Tablet contains:
Pseudoephedrine ……36mg
Triprolidine….1.5mg
Paracetamol……..300mg
3. Sorefix-DX Tablets
Each Tablet contains:
Pseudoephedrine ……..90mg
Triprolidine……2.5mg
Clemastine as hydrogen fumarate…..1mg
4. Sorefix Tablets
Pseudoephedrine ……….60mg
Triprolidine …………2.5mg

The firm submitted the following documents.

i. Fee i.e. Rs.20000/-for the each products.
ii. Copy of form 5
iii. Copy of export order from Hong Kong.
Registration Board in its 237th meeting referred the case to committee on
controlled drugs, Narcotic Control Division for its recommendation and authorized
Chairman Registration Board to take decision for the grant of export registration or
otherwise in light of recommendation of the committee and submission of differential
fee.
Committee of the allocation of controlled drugs in its 11th meeting held on 6th
May, 2013 decided that Registration Board may consider the registration of Controlled
Drugs for export and local manufacturing in the light of relevant Act and rules and the
Committee on the allocation of controlled drugs will consider matter for allocation of
Controlled Drugs in the light of relevant laws and rules after registration.

Decision: Committee on allocation of controlled Drug has already conveyed that

Registration Board may take decision according to its rules. Thus Board approved
firm’s request. Matter regarding allocation of quota will be dealt by Committee on
allocation of controlled Drug accordingly.

71
 Case No. 41. M/s. Highnoon Laboratories Ltd Lahore.
Following products of M/s. Highnoon Laboratories Ltd Lahore were deferred for expert
opinion. Two experts gave their recommendations while the opinion of 3rd expert was
awaited. The Drug Registration Board in its 237th meeting referred these products for expert
opinion to Brig. (R).Prof. Dr. Muzammil Hasan Najmi after submission of differential fee.
Now opinion of all experts has received as under:-

Name of Products MRP/ Name of Expert Comments by the Brig. (R).Prof. Dr.
Pack expert Muzammil Hasan
Size. Najmi
Pidogrel-CAP 75 Rs.215.0 Prof.Dr. As this product is This is a combination of
Each capsule contains:- 0/10’s Mahmood Ahmad already manufactured by clopidogrel with enteric
Clopidogrel (as Faculty of the same company under coated aspirin pallets in
bisulphate) ……75mg pharmacy and Re. No. 038902 in tablet capsule form. A
Aspirin (as enteric alternative form and according to combination of
coated pellets) 75mg medicine, the available literature clopidogrel with aspirin
The Islamia and stability data without enteric coating
University of provided both the is already being
Bahawalpur strengths of pidogrel are marketed by the same
stable and retain its manufacturer and some
efficacy in combination other companies. The
in capsule form. two drugs in
Therefore, the pidogrel- combination are platelet
Cap 75mg & pidogrel- inhibitors acting by
Cap 150mg may be independent different
registered. mechanisms. These are
used in treatment and
prophylaxis of
thromboembolic
disorders. However their
use in the form of a
fixed dose combination
is not approved by FDA
of USA.
In the formulation under
review, aspirin has been
replaced with enteric
coated aspirin and the
dosage form has been
changed from tablet to
capsule. Dissolution
profile of the new

72
 dosage form has been
submitted by the
manufacturer which
shows satisfactory
pattern of dissolution.
In view of the
registration and
availability of
combinations of
clopidogrel and aspirin
in Pakistan, Pidogrel-
CAP 75 is
recommended for
registration.

Pidogrel-CAP 150 Rs.225.0 Brig Syed M. Preparations are

Each capsule contains:- 0/10’s Imran Majeed considered suitable for
Clopidogrel (as registrations.
bisulphate) ……75mg
Aspirin (as enteric
coated pallets) 150mg
Dr. Iqbal The products are
Saifullah Head of recommended for
Cardiology PIMS registration.
Islamabad
Loprin-AT Capsules Rs.300.0 Prof.Dr.Muhamm This combination of It is a combination of
Each capsule contains:- 0/10’s ad Ishaq Karachi Atorvastatin and Asprin Atorvastatin with enteric
Atorvastatin (as Institute of Heart can be used for CAD coated aspirin.
calcium trihydrat) Diseases Karachi patients and potential Atorvastatin is an
………….10mg patients. Both drugs as inhibitor of HMG Co A
Aspirin (as enteric individual molecules are Reductase enzyme and
coated pallets) established sherapeutic helps to lower
…………… 75mg agents as lipid lowering cholesterol level in
and antiplatlets. The patients of dyslipidemia
advantages of while aspirin is an
combination include Antiplatelet drug used to
beeter compliance at treat and prevent
reduced cost. However thromboembolism.
being fixed combination While the two drugs
the side effects can be may be required to be
difficuit to as ses. The used together in several
only major country patients, their
having this combination availability in a fixed
is India as such there are dose combination is not
no reasons against this supported by the
formulation to be made scientific literature.

73
 available in Pakistan. Such combination is not
approved by FDA of
USA and European
Medicines Agency.
Loprin-AT is therefore
NOT
RECOMMENDED for
registration.

Dr. Iqbal Additive effect of

Saifullah antiplatelet therapy and
Head of cholesterol lowering
Cardiology PIMS agent has been proved in
Islamabad reducing cardiovascular
events. Combination of
these two agents reduces
the risk of
cardiovascular mortality
in non-diabetic patients
with known IHD as well
as coronary artery
disease diabetics.
Combination of asprin
and Atorvastatin is
widely used in Pakistan.
Fixed dose combination
will also provide better
patient compliance.
Loprin AT is
recommended for
registration.
Syed Khalid Aspirin has been used as
Saeed Bukhari very effective
WHO Country antiplatelet therapy in
advisor/NPO cardiovascular diseases,
Essential while Atorvastatin is
medicines antihyperlipidemic and
Pakistan used to lower
cholesterol levels.
Combination of these
two agents reduces the
risks of cardiovascular
mortality in non diabetic
patients with known
IHD as well coronary
artery disease diabetics.

74
 Fixed dose combination
of these tow agents is
available in other
countries. Loprin-At
Capsule which is a
combination of
atorvastatin and enteric
coated aspirin pallets
will offer the benefit of
combined aspirin with
statin therapy.
Aspirin is present as
enteric coated pellets
therefore it will avoid
aspirin related GI side
effects leading to cost
effective therapy.
Aspirin is present as
enteric coated pallets
therefore it will avoid
aspirin related GI side
effects leading to
costeffectiveness; it will
definitely increase better
patient compliance. So
product may be
recommended for
registration with
positive opinion.

Nebizide 10 Tablet Rs.735.0 Prof.Dr.Muhamm Nebivolol is a novel

Each tablet contains:- 0/14’s ad Ishaq Karachi cardioselective beta
Nebivolol (as Institute of Heart blocker being used as an
HCl)…..10mg Diseases Karachi effective
Hydrochlorthiazide….1 Antihypertensive. It’s
2.5mg unse in Heart failure is
not recommended so far.
The molecule is FDA
approved bot separately
and in combination.
Recommend the
availability of this
product for our
hypertensive patints.
Fised dose combination
of these two products

75
 are already available in
other ountries.
Nebizide 5 Tablet Rs.385.0 -do- Both strength are This is a combination of
Each tablet contains:- 0/14’s recommended Nebivolol with
Nebivolol (as Hydrochlorothiazide.
HCl)…..5mg Nebivolol is a beta
Hydrochlorthiazide….1 blocker with high degree
2.5mg of selectivity for beta 1
receptors and additional
vasodilator property.
Like other beta blockers,
it is used for treatment
of hypertension and
other cardiovascular
diseases.
Hydrochlorothiazide is a
diuretic which is also
useful in hypertension.
Studies have been
reported in scientific
literature showing a
synergistic action of the
two drugs in
hypertension. Many
other beta blockers are
also available in
combination with
thiazide diuretics.
Nebizide 5 mg and 10
mg is therefore,
recommended for
registration.
Syed Khalid Nebivolol is a beta
Saeed Bukhari blocking drug used for
WHO Country hypertension while
advisor/NPO hydrochlorothiazide is
Essential antidiuretic which is
medicines also used as
Pakistan antihypertensive.
Combination of
Nebivolol and
Hydrochlorothiazide has
been evaluated in large
scale clinical trials.
Nebivolol and HCTZ is
and effective and well

76
 tolerated therapeutic
strategy for management
of hypertension
including diabetic and
elderly patients.
Combination of these
two products called
Nebizide is fixed dose
which is bioequivalent
to the two agents
administered
concomitantly.
This combination is
useful as monotherapy
nonresponders and for
those who required rapid
BP control to prevent
end organ damage.
Post marketing
surveillance studies
published so far has
shown that drug is
effective and well
tolerated therapeutic
strategy in clinical trials.
SO product may be
recommended for
registration with
positive opinion.

Decision: The Board decided following:

Pidogrel-CAP 75: Deferred for the confirmation of approval of formulation

by USFDA, EMA, TGA, and Japan.
Pidogrel-CAP 150: Deferred for the confirmation of approval of formulation
by USFDA, EMA, TGA, and Japan.
Loprin-AT Capsules: Deferred, as the formulation is not approved by US-
FDA, EMA, TGA, Japan.
Nebizide 10 Tablet: Deferred for the confirmation of approval of formulation
by FDA, EMA, TGA, and Japan
Nebizide 5 Tablet: Deferred for the confirmation of approval of formulation
by FDA, EMA, TGA, and Japan

Case No. 42. M/s. Shrooq Pharma Lahore.

77
 M/s. Shrooq Pharma Lahore applied for following applications. These were
considered in 235th meeting of Drug Registration Board Held On 18th September 2012
and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman, member
Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC after
completion of files. The meeting of the subcommittee was held on 08-11-2012 but
complete dossiers were not received at that time. Now the firm has submitted differential
fee and duplicate dossiers (photocopies) of these products and has requested for the
registration of these products.

S Name of Name of the Pack Size Proposed Decision in the Remarks

.No Firm drugs with Price 235th meeting.
composition
1. M/s. Isono Tablets 10’s As Per Approved subject Me-too status of
Shrooq 10mg SRO to the submission 10mg tablets not
Pharma Each tablet of duplicate files confirmed. S.No
Lahore contains:- and completion of 14 of form 5 not
March, Isotretinon…..1 registration correct.
2010 0mg dossier and Dissolution test
(Dermatologica recommendations method not
l) of the committee provided.
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.

2. -do- Isono Tablets 10’s As Per -do- S.No 14 of form 5

20mg SRO not correct.
Each tablet Dissolution test
contains:- method not
Isotretinon…..2 provided.
0mg
(Dermatologica

78
 l)

3. -do- Micin-T Lotion 30ml -do -do- The firm has no

Each ml external liquid
contains:- preparation
Clindamycin section; however
(phosphate)…. oral liquid and
10mg semi solid sections
(antifungal) are present.

4. -do- Lumart-Forte 6’s -do- -do- No comments

Dispersible
Tablets
Each tablet
contains:-
Artemether
….80mg
Lumefantrin….
480mg
(anti Malarial)

5. -do- Benz-C Lotion 30ml As Per Approved subject Confirmation of

Each ml SRO to the submission me-too status?
contains:- of duplicate files S.No 13 of Form 5
Clindamycin and completion of not correct (Clycin
(phosphate)… registration Plus Lotion not
….10mg dossier and found). The firm
Benzyl recommendations has no external
peroxide….50 of the committee liquid preparation
mg comprising of section; however
(Antifungal Prof. Rafi-Uz- oral liquid and
and Zaman, member semi solid sections
dermatological) Registration are present.
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.

79
6. -do- Duaba Sachet 10’s -do- -do- Saccharin sodium
Each sachet 3.5g per sachet=
contains:- 50%.
Strontium
ranelate….2.00
g

7. -do- Clerox Liquid 60ml As per -do- The firm has no

Each 5ml SRO external liquid
contains;- preparation
Ciclopirox section; however
Olamine….1.5 oral liquid and
% semi solid sections
(Anti-fungal) are present. Me-
too status not
confirmed.
Stieprox by stiefel
not found in
Pharmaguide,
however pricing
minutes mention it
with Salycilic acid
which is not
present in this
formulation.
8. -do- Medison 5g As per Approved subject The firm has no
Cream SRO to the submission semi solid
Each gram of duplicate files steroidal section.
contains:- and completion of Raw material
Mometasone registration specifications not
Furoate……… dossier and provided.
0.1% recommendations
(Corticosteroid of the committee
s) comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the

80
 firm.

9. -do- Sugrel Tablets 10’s Rs.1275.0 Approved subject S.No 13 of Form 5

Each tablet 20’s 0 to the submission not filled.
contains:- Rs.2550.0 of duplicate files
Prasugrel 0 and completion of
Hydrochloride registration
…………….5 dossier and
mg recommendations
(Platelet of the committee
aggregation comprising of
inhibitor) Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.

10. -do- Sugrel Tablets 10’s Rs.640.00 Deferred for S.No 13 of Form 5
Each tablet 20’s Rs.1280.0 confirmation of not filled.
contains:- 0 formulation, Me-too status not
Prasugrel submission of confirmed in 2.5
Hydrochloride duplicate file and mg strength.
…………….2. completion of
5mg registration
(Platelet dossier.
aggregation
inhibitor)
11. -do- Scabease 10’s As per Approved subject
Tablets SRO to the submission
Each tablet of duplicate files
contains:- and completion of
Ivermectin…… registration
……….6mg dossier and
(Anti-parasitic recommendations
and Anti- of the committee
scabietic) comprising of
Prof. Rafi-Uz-
Zaman, member

81
 Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.

12. -do- Lite Orange 10’s Rs.196.00 -do-/ and also Formulation is
Sachet subject to WHO according to
Each sachet formulation. WHO.
contains:- Saccharin sodium
Sodium 3.5g per
citrate……… sachet=14.28%
…..2.9
Sodium
Chloride……
……..2.6g
Potassium
chloride………
.1.5g
Dextrose
monohydrate…
……….13.50g
(Electrolyte)

13. -do- Lumart 16’s As per Approved subject Confirmation of

Dispersible SRO to the submission me-too status in
Tablets of duplicate files Dispersible form.
Each tablet and completion of
contains:- registration
Artemether… dossier and
………20mg recommendations
Lumefantrine of the committee
…………..120 comprising of
mg Prof. Rafi-Uz-
(Anti-Malarial) Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and

82
 concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.

Decision: The Board decided following:

Isono Tablets 10mg: Deferred for confirmation of Me-too status of 10mg
tablets, submission of new complete signed form 5 and dissolution test
method.
Isono Tablets 20mg: Approved. However the Board advised to submit new
complete signed Form 5 and dissolution test method.
Micin-T Lotion: Rejected as the firm has no external liquid preparation
section.
Lumart-Forte Dispersible Tablets: Approved.
Benz-C Lotion: Rejected as the firm has no external liquid preparation
section.
Duaba Sachet: Deferred for clarification of master formula and change of
inactive ingredients according to FDA limits.
Clerox Liquid: Rejected as the firm has no external liquid preparation
section.
Medison Cream: Deferred till decision of semi solid steroidal products in
semi solid general section by licensing section and submission of raw material
specifications.
Sugrel Tablets 5mg: Approved. However the Board advised to submit new
complete and signed form 5.
Sugrel Tablets 2.5 mg: Deferred for confirmation of me-too status in 2.5 mg
strength and submission of new complete and signed form 5.
Scabease Tablets: Approved. The firm shall propose other brand names
which do not resemble with already registered brands.
Lite Orange Sachet: Deferred for clarification of master formula and change
of inactive ingredients according to FDA limits.
Lumart Dispersible Tablets: Deferred for confirmation of Me-too status in
dispersible form.

Case No. 43. M/s Pacific Pharma, Lahore.

Following application of M/s Pacific Pharma, Lahore was rejected in 189th

Meeting of the Registration Board because the experts did not recommend the product for
registration.

83
 The firm got registration of the product for export purpose and applied for transfer of
registration from export to local manufacturing on 02-07-2010 on form-5D.
Now the firm has submitted the differential fee and requested for the registration of the
product because according to them the product is registered in countries like Germany,
Italy, Belgium, Spain, Greece, and Portugal.
Name of Name of the drugs with Pack Size Proposed Price Date of Remarks
Firm composition Submission
M/s Pacific Exituss Syrup 60ml Rs. 195/- 02-07-2010 Form-5 D ,
Pharma, Each 5 ml contains:- 120ml Rs.390/- (Rs. 8000/- New
Lahore. Levodropropizine…30mg +Rs.15000/- application.
(Anti-tussive) +Rs.27000/-)

Decision: Registration Board deferred the case for confirmation of availability of

formulation in USFDA, EMA, Australia or Japan.

Case No.44. M/s Rasco Pharma, Lahore.

Director (Quality Control) has informed that M/s Rasco Pharma, Lahore has
manufactured Nil-Gesic Tablets which is counterfeit of Wilgesic Tablets manufactured
by M/s Wislon Pharmaceuticals, Islamabad.
He has directed the DDG (E&M) Lahore to inspect the premises and to rectify the
counterfeit packing and has requested the Drug Registration Board for cancellation of
registration of counterfeit Nilgesic manufactured by M/s Rasco Pharma, Lahore.
In this regard the FID Lahore-II has inspected the premises of the firm and he has
observed that no stock of packing of counterfeit “Nil-Gesic Tablet” was found in the
premises.
Meanwhile M/s. Rasco Pharma, Lahore has requested for change of packing
design of counterfeit “Nil-Gesic Tablet” and has submitted following documents:-
i. Undertaking that all of their current and future production will be packed
in new design of carton & Aluminum foil.
ii. Undertaking that their product “Nilgesic Tablet” with existing packing
material/design is not available in the market and has been withdrawn
from the market and there is no case pending/under process in any Court
of Pakistan and the firm has also undertake that their proposed packing
design does not resemble with already available drugs.
iii. Prescribed fee of Rs. 5000/- for the purpose.

84
 Later on the firm was asked to why they have change the packing design without
prior approval of the Drug Regulatory Authority of Pakistan. As per reply of the firm and
FID report the firm was manufacturing the said drug in its original approved packing, but
on the demand of marketing department they manufactured only three batches of the
product without approval from DRAP. According to the firm as soon as they came to
know about the resemblance, they stopped manufacturing and have requested to change
the design again to its original approved packing and have tender apology for this act.
Decision: The Drug Registration Board decided to approve the packing design and
directed to change the name of the product immediately. The Board also decided to
issue warning to the firm and advised to be careful in future.

Case No.45. M/s. Mediways International, Lahore.

The Drug Registration Board in its following meetings had deferred the following
products of M/s. Mediways International, Lahore as mentioned in relevant column for
each product. The firm has deposited remaining fee of Rs. 12000/- for each product and
provided copy of inspection report dated 19-06-2013 in which the panel has verified that
the firm has installed HVAC in the manufacturing area of the premises. They have
requested to grant them the registration of these products.

Brand Name/Label claim Demande Demand Decision of Remarks

d Pack ed Price Board
size
Coftus Syrup 5ml Rs.2.25 Deferred Formulation
Each 5ml contains:- (M-223) contains
Dextromethorphan HBr Pseudoephe
BP…..10mg drine
Pseudoephedrine HCl
BP…….30mg
Chloropheniramine Maleate
BP.......2mg

Flucof Syrup 5ml Rs.2.50.0 Deferred Formulation

Each 5ml contains:- 60ml 0 (M-223) contains
Paracetamol B.P 120ml Rs.30.00 Pseudoephe
…………....325mg Rs.60.00 drine
Dextromethorphan HBr

85
B.P….10mg
Pseudoephedrine HCl
B.P……30mg
Chloropheniramine as
maleate…..1mg
(analgesic)

Vomax Suspension. 60ml Rs.2.50/ Deferred till the firm has

Each 5ml Contains:- 5ml. the installed
Domperidone B.P………5mg. installation HVAC
of HVAC.
(M-201)
Certex Syrup. 60ml. Rs.3.08/ -do- the firm has
Each 5ml Contains:- 5ml. (M-201) installed
Cetirizine HCl B.P eq. to HVAC
Cetirizine base……….5mg.

Neurotone Syrup 5ml Rs.15.42 Deferred for The firm has

Each 5ml contains:- 120ml Rs.370.0 Licensing installed
Piracetam ………………1.0gm 0 section’s HVAC. The
comments molecule is
on under
requirement review.
of HVAC in
Syrup
section.
(M-225)
Nu-Fer Syrup 60ml Rs.6.60 -do- The firm has
Each 5ml contains:- 120ml per 5ml installed
Iron (III) Hydroxide Polymaltose HVAC.
Complex Eq. to elemental
Iron…………..…..50mg
Folic Acid………...0.35mg

Decision: Registration Board decided as follows:

Coftus Syrup: Deferred till decision on controlled drugs.
Flucof Syrup: Deferred till decision on controlled drugs.
Vomax Suspension: Approved.
Certex Syrup: Approved.
Neurotone Syrup: Deferred for review committee as the formulation is under
review.

86
 Nu-Fer Syrup: Deferred for product specific inspection by Director DTL,
Lahore, DDG E&M, Lahore and Area FID

Case No. 46. M/s. English Pharmaceutical Industries Lahore.

M/s. English Pharmaceutical Industries Lahore applied for following applications.

These were considered in 235th meeting of Drug Registration Board Held On 18th
September 2012 and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman,
member Registration Board, Secretary Registration Board, DDG (Reg) and concerned
DDC after completion of files. The meeting of the subcommittee was held on 08-11-2012
but complete dossiers were not received at that time. Now the firm has submitted
differential fee and new dossiers of these products and has requested for the registration
of these products.

S Name of Name of the drugs Pack Proposed Decision in the 235th

.No Firm with composition Size Price meeting.
1 M/s. Zital 20mg Tablet 10’s As per Approved subject to the
English Each tablet S.R.O submission of duplicate
Pharma contains:- files and completion of
Lahore. Escitalopram (as registration dossier and
oxalate)….20mg recommendations of the
committee comprising
of Prof. Rafi-Uz-Zaman,
member Registration
Board, Secretary
Registration Board,
DDG (Reg) and
concerned DDC. Five
products per section will
be granted on the
priority list of the firm.

2 -do- X-Ron 15mg Tablets 10’s -do- Approved subject to the

Each tablet submission of duplicate
contains:- files and completion of
Mirtazapin….15mg registration dossier and
recommendations of the
committee comprising
of Prof. Rafi-Uz-Zaman,
member Registration
Board, Secretary

87
 Registration Board,
DDG (Reg) and
concerned DDC. Five
products per section will
be granted on the
priority list of the firm.

3 -do- X-Ron 30mg Tablets 10’s -do- -do-

Each tablet
contains:-
Mirtazapin….30mg

Decision: Registration Board approved above products for registration. Brand

name of Zital tablets will be changed.

Case No.47. Extension in Contract Manufacturing

S.No Applicant Contract Reg. No. Name of Drug (s) & Date of Category
manufacturer Composition application,
and Form.
1. M/s. Feroza M/s. 024050 Ferophin injection IM 26-08- Dedicated
International Medisave Each vial contains:- 2013 section
Pharma Pharma Ceftriaxone sodium Rs.50000/-
Lahore Lahore eq.to Form 5
Ceftriaxone…..250mg
(anti-Biotic)
2. -do- -do- 024051 Ferophin injection IM 26-08- Dedicated
Each vial contains:- 2013 section
Ceftriaxone sodium Rs.50000/-
eq.to Form 5
Ceftriaxone…..500mg
(anti-Biotic)
3. -do- -do- 024055 Ferophin injection IV 26-08- Dedicated
Each vial contains:- 2013 section
Ceftriaxone sodium Rs.50000/-
eq.to Form 5
Ceftriaxone…..1gm
(anti-Biotic)
4. -do- -do- 024054 Ferophin injection IV 26-08- Dedicated
Each vial contains:- 2013 section
Ceftriaxone sodium Rs.50000/-
eq.to Form 5
Ceftriaxone…..500mg
(anti-Biotic)
5. M/s. Allmed M/s. 045001 Ivoryzone 1gm 12-8-2013 Dedicated
(Pvt) Ltd, Medisave Injection Rs.50000/- section
(formall Pharma Each vial contains:- Form 5

88
 M/s. Lahore Ceftriaxone (as
Evergreen sodium)….1gm
Pharma
Lahore
6. -do- -do- 045014 Rutex 400mg Caspule 12-8-2013 Dedicated
Each capsule Rs.50000/- section
contains:- Form 5
Cefixime……400mg

7. -do- -do- 045013 Rutex 100mg Dry 12-8-2013 Dedicated

Suspension Rs.50000/- section
Each 5ml contains:- Form 5
Cefixime……100mg
8. -do- -do- 044491 Greenec 2gm Injection 12-8-2013 Dedicated
Each vial contains:- Rs.50000/- section
Cefoperazone (as Form 5
sodium)…..1.0gm
Sulbactam (as
sodium)….1.0gm
9. -do- -do- 045002 Ivoryzone 500mg 12-8-2013 Dedicated
Injection Rs.50000/- section
Each vial contains:- Form 5
Ceftriaxone (as
sodium)….500mg
10. -do- -do- 044493 Puna 1.0gm Injection 12-8-2013 Dedicated
Each vial contains:- Rs.50000/- section
Cefepime (as Form 5
HCl)…..1.0gm
11. -do- -do- 044490 Greenec 1gm Injection 12-8-2013 Dedicated
Each vial contains:- Rs.50000/- section
Cefoperazone (as Form 5
sodium)…..500mg
Sulbactam (as
sodium)….500mg
12. -do- -do- 044493 Puna 500mg Injection 12-8-2013 Dedicated
Each vial contains:- Rs.50000/- section
Cefepime (as Form 5
HCl)…..500mg
13. -do- -do- 045003 Ivoryzone 250mg 12-8-2013 Dedicated
Injection Rs.50000/- section
Each vial contains:- Form 5
Ceftriaxone (as
sodium)….250mg

Decision: Registration Board extended above products till 30.06.2015. The

Board advised the firms to select either IM or IV for products at S.No. 5, 9 and 13.

89
 Item No.IV New Section-New License-Anomly cases:

Registration-II
a. M/S, City Pharmaceuticals, Karachi
Capsule (General)

231st RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Decision

Composition Pack size Price application,
Diary No. &
Form
1 Orex-500mg Capsule As per As per PRC 27-03-2013 Approved
Each capsule contains: PRC Dy.No.191 However the
Cefadroxil………500 mg Form-5 Registration
(Anti bacterial/Antibiotic) Rs.20,000/- Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters

Suspension (Cephalosporin)

231st RB meeting: 04
S.No. Name of drug(s) & Proposed Demanded Date of Remarks
Composition Pack size Price application,
Diary No. &
Form
1 Orex-250mg Dry Suspension As per As per PRC 27-03-2013 Approved
Each 5ml contains: PRC Dy.No.190 However the
Cefadroxil………250 mg Form-5 Registration
(Anti bacterial/Antibiotic) Rs.20,000/- Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration

90
 letters
2 Orex-125mg Dry Suspension As per As per PRC 27-03-2013 -Do-
Each 5ml contains: PRC Dy.No.189
Cefadroxil……125 mg Form-5
(Anti bacterial/Antibiotic) Rs.20,000/-

b. M/S, Kaizen Pharmaceuticals, Karachi.

Dry Powder Suspension Section.

235th RB meeting: 05
236th RB meeting: 04
S.No. Name of drug(s) & Proposed Demanded Date of Remarks
Composition Pack size Price application,
Diary No.
& Form
1 Proart Dry Suspension 30ml As per PRC 08-11-2012 Deferred for
Each 5ml contains: 40ml Dy.No.1766 me too staus
Dihydroartemisinin..15mg 60ml -A &
Piperaquine 80ml Form-5 confirmatio
phosphate……..…120 mg Rs.20,000/- n of WHO
(Anti malarial) approved
formulation

c. M/s, Reign Pharmaceuticals PCSIR-KLC (Pvt.) Ltd, Karachi

Tablet (General).
235th RB meeting: 05
S.No. Name of drug(s) & Proposed Demanded Date of Remarks
Composition Pack size Price application,
Diary No.
& Form
1 Montikol 10mg Tablet As per As per PRC 21-05-2013 Approved
Each tablet contains: PRC Dy.No.528 However the
Montelukast Form-5 Registration
Sodium………….10 mg Rs.20,000/- Board
(Is oral leukotriene advised the
registration
receptor antagonist)
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Spastol Tablet As per As per PRC 21-05-2013 Deferred for
Each tablet contains: PRC Dy.No.529 review

91
 Phloroglucinol ……80 mg Form-5 committee
Trimethylphloroglucinol… Rs.20,000/- consideration
…………………..80 mg
(Antispasmodic)

Capsule (General)
235th RB meeting: 05
S.No. Name of drug(s) & Proposed Demanded Date of Remarks
Composition Pack size Price application,
Diary No.
& Form
1 Fluben 100mg Capsule As per As per PRC 21-05-2013 Approved
Each capsule contains: PRC Dy.No.531 However the
Flurbiprofen……100 mg Form-5 Registration
(NSAID) Rs.20,000/- Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Omzol 40mg Capsule As per As per PRC 21-05-2013 -Do-
Each capsule contains: PRC Dy.No.532
Omeprazole……..40 mg Form-5
(Proton pump inhibitor) Rs.20,000/-

3 Omzol 20mg Capsule As per As per PRC 21-05-2013 -Do-

Each capsule contains: PRC Dy.No.530
Omeprazole……..20 mg Form-5
(Proton pump inhibitor) Rs.20,000/-

Dry Powder (Suspension)

235th RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Remarks

Composition Pack size Price application,
Diary No.
& Form
1 Fosfon 250mg/5ml oral As per As per PRC 21-05-2013 Approved
Suspension PRC Dy.No.533 However the

92
 Each 5ml contains: Form-5 Registration
Fosfomycin Rs.20,000/- Board
Sodium………….250 mg advised the
(Broad Spectrum registration
Antibiotic of macrolide sections to
again review
group)
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Renflox 250mg/5ml Dry As per As per PRC 21-05-2013 -Do-
Powder Suspension PRC Dy.No.535
Each 5ml contains: Form-5
Ciprofloxacin ….250 mg Rs.20,000/-
(Antibiotic)
3 Zinkid 20mg/5ml Susp. As per As per PRC 21-05-2013 -Do-
Each 5ml contains: PRC Dy.No.534
Zinc Sulphate ……20 mg Form-5
(Astringent (for zinc Rs.20,000/-
deficiency)

Sachet Section.
235th RB meeting: 03

S.No. Name of drug(s) & Proposed Demanded Date of Remarks

Composition Pack size Price application,
Diary No.
& Form
1 Lotrol Low Osmolarity As per As per PRC 21-05-2013 Deferred for
Sachet PRC Dy.No.540 confirmatio
Each sachet contains: Form-5 n of WHO
Sodium chloride….1.3g Rs.20,000/- approved
Potassium Chloride..0.75g formula
Trisodium Citrate
Dihydrate…….1.45 g
Glucose anhydrous…6.75g
Eq. to sodium 37.5mmol,
Potassium10.00mmol,
chloride 32.5mmol, citrate
5.00mmol, Glucose
37.5mmol.
(Low-Osmolarity

93
 electrolytes/ORS)
2 Fem-C Plus Sachet As per As per PRC 21-05-2013 Referred to
Each sachet contains: PRC Dy.No.539 review
Calcium Gluconate..587mg Form-5 committee
Calcium carbonate..327mg Rs.20,000/- for
Calcium lactate…422 mg evaluation
Asc orbic acid….500 mg
Cyanocobalamin..250 mcg
Folic acid…………1 mg

Liquid Syrup.
235th RB meeting: 02

S.No. Name of drug(s) & Proposed Demanded Date of Remarks

Composition Pack size Price application,
Diary No.
& Form
1 Anafe-F Syrup As per As per PRC 21-05-2013 Deferred for
Each 15ml contains: PRC Dy.No.527 confirmation
Iron Protein Succinylate Form-5 of me too
800mg eq. to elemental Rs.20,000/- status
Iron ………….40 mg
Folic acid………..2.5 mg
(Anaemia, Haematinic)
2 DuMol Syrup As per As per PRC 21-05-2013 Approved.
Each 5ml contains: PRC Dy.No.536 The Board
Paracetamol…….120 mg Form-5 advised to
(Analgesic and antipyretic) Rs.20,000/- change brand
name.
The
Registration
Board also
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
3 Irofer-F Syrup As per As per PRC 21-05-2013 Deferred for
Each 5ml contains: PRC Dy.No.541 PSI by
Iron (III) Hydroxide Form-5 Director
polymaltose complex eq.t o Rs.20,000/- DTL,
Karachi and

94
 elemental iron …..50mg area FID
Folic acid………0.35 mg
(For iron deficiency
anemia, haematinic)
4 Irol-F Syrup As per As per PRC 21-05-2013 Deferred for
Each 5ml contains: PRC Dy.No.538 confirmation
Iron Polysacharide Form-5 of me too
complex eq.t o elemental Rs.20,000/- status and
Iron ………..100 mg PSI by
Director
Folic Acid………..0.35 mg
DTL,
(For iron deficiency Karachi and
anemia, haematinic) area FID
5 Nuprin 100mg Suspension As per As per PRC 21-05-2013
Each 5ml contains: PRC Dy.No.537 Approved
Ibuprofen………100 mg Form-5
(Analgesic and antipyretic Rs.20,000/-
NSAID)

Registration-V

S. No Name of Name of the drugs with composition Pack Proposed Date of Decsion
Firm Size Price Submission
1. M/s. Simz Diclosim-75mg Tablets 10’s As Per 18-7-2013 Deferred
Pharma Each tablet contains:- SRO 20000/- for
Lahore Diclofenac Potassium ….75mg submission
(analgesic) of Raw
material
specificatio
ns and latest
GMP
Inspection
report.
2. -do- Simfexo 60mg Tablets 10’s -do- 18-7-2013 -Do-
Each tablet contins:- 20000/-
Fexofenadine HCl….60mg
(anti allergic)

3. -do- Simfexo 120mg Tablets 10’s -do- 18-7-2013 -Do-

Each tablet contins:- 20000/-
Fexofenadine HCl….120mg
(anti allergic)

4. -do- Simfexo 180mg Tablets 10’s -do- 18-7-2013 -Do-

Each tablet contins:- 20000/-

95
 Fexofenadine HCl….180mg
(anti allergic)

5. -do- Zithosim 500mg Tablets 6’s -do- 18-7-2013 -Do-

Each tablet contains:- 20000/-
Azithromycin as
dihydrate…500mg
(macrolide antibacterial)

6. -do- Diclosim 100mg SR Tablets 10’s -do- 18-7-2013 -Do-

Each tablet contains:- 20000/-
Diclofenac potassium….100mg
(analgesic)
7. -do- Simclar 250mg Tablets 10’s -do- 18-7-2013 -Do-
Each tablet contains:- 20000/-
Clarithromycin….250mg
(antibiotic)

8. -do- Simclar 500mg Tablets 10’s -do- 18-7-2013 -Do-

Each tablet contains:- 20000/-
Clarithromycin…..500mg
(antibiotic)
9. -do- Omepza 40mg Capsule 14’s -do- 18-7-2013 -Do-
Each capsule contains:- 20000/-
Omeprazole enteric coated
Pellets…..40mg
(proton pump inhibitor)

10. -do- Fansimz 80-480mg Tablets 7’s -do- 18-7-2013 -Do-

Each tablet contains:- 20000/-
Artemether….80mg
Lumefentrine….480mg
(anti malarial)

11. -do- Fansimz 15/90mg Dry 60ml -do- 18-7-2013 -Do-

Suspension 20000/-
Each 5ml contains:-
Artemether…15mg
Lumefentrine…90mg
(anti malarial)

12. M/s. Amrosal Syrup 60ml As Per 22-5-2013 Deferred

Novartana Each 5ml contains:- SRO Rs.20000/- for
confirmati

96
 Pharma Ambroxol as HCl……15mg on of me
Lahore Salbutmol…..1gm too status,
Guaphenesin…..50mg Submissio
n of
Menthol….1mg
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.
13. -do- Acnov 20mg Capsule 10’s -do- 22-5-2013 Deferred
Each capsule contains:- Rs.20000/- for
Isotretinoin…..20mg Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.
14. -do- Acnov 10mg Capsule 10’s -do- 22-5-2013 Deferred
Each capsule contains:- Rs.20000/- for
Isotretinoin…..10mg Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati

97
 ons.
15. -do- Vantrin Suspension 60ml -do- 22-5-2013 Deferred
Each 5ml contains:- Rs.20000/- for
Artemether……15mg Submissio
Lumefantrine….90mg n of
correct
signed
application
on form 5,
verificatio
n of
product for
dry
suspension
as
formulatio
n contains
water and
raw
materials
and
finished
product
specificati
ons.
16. -do- Irofer Syrup 120ml -do- 22-5-2013 Deferred
Each 15ml contains:- Rs.20000/- for
Iron protein succinylate Submissio
complex 800mg equivalent to n of
40mg elemental iron correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.

98
17. -do- Prebalin 75mg Capsule 10’s -do- 22-5-2013 Deferred
Each capsule contains:- Rs.20000/- for
Pregabalin….75mg Submissio
n of
correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
18. -do- Prebalin 150mg Capsule 10’s -do- 22-5-2013 Deferred
Each capsule contains:- Rs.20000/- for
Pregabalin….150mg Submissio
n of
correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
19. -do- Orthin 50mg Capsule 10’s -do- 22-5-2013 Deferred
Each capule contains:- Rs.20000/- for
Diacerein….50mg Submissio
n of

99
 correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
20. -do- Amrosal Syrup 60ml -do- 22-5-2013 Duplicate
Each 5ml contains:- Rs.20000/- entry
Ambroxol as HCl……15mg
Salbutamol….1mg
Guaphenesin….50mg
Menthol….1mg

21. -do- Olit Capsule 30’s As Per 1-8-2013 Deferred

Each capsule contains:- SRO Rs.20000/- for
Orlistat…..120mg Submissio
n of
GMP
Certificate
of pellets
manufactu
rer,
Certificate
of
Analysis
and
stability
studies of
pellets.

22. -do- Irofol Syrup 120ml -do- 1-8-2013 -Do-

Each 5ml contains:- Rs.20000/-
Iron (III) Hydroxide
polymaltose complex….50mg

100
 Folic Acid…..0.35mg

23. -do- Tamo Capsule 20’s -do- 1-8-2013 Deferred

Each capsule contains:- Rs.20000/- for
Tamsulosin HCl…….0.4mg Submissio
n of
GMP
Certificate
of pellets
manufactu
rer,
Certificate
of
Analysis
and
stability
studies of
pellets.

24. -do- Amrosal Syrup 120ml -do- 21-7-2013 Duplicate

Each 5ml contains:- Rs.20000/- entry
Ambroxol as HCl……15mg
Salbutamol BP……1mg
Guaphenesin BP…..50mg
Menthol BP….1mg

101
Item No. V. Quality Control cases

Case No.01: Deferred Cases

Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision

#

1. Pamectin Drench M/s. Nawan Substandard in Not challenged Samples drawn from manufacturer’s premises on
Laboratories respect of Assay 25-02-2013 by FID Karachi-III. The firm could not
Batch NO. (Pvt) Ltd., for Ivermectin: provide any valid justification for non conformance
V026/PMC/H/23 Animal of the product, in question, with the specifications.
(Levermectin) Health Show Cause Notice, for cancellation / suspension
Division Percentage: 44.8% of registration / prosecution, was issued on 04-05-
(F. No. 3-16/2013- Karachi. 2013. Accused Licensee namely Naseer Ahmed
QC) Limits: 90.0 % to Awan, Muhammad Akram Rana, Mohammad
110.0% Does not Younus and the Firm / their Representative were
comply with called for personal hearing before 238th DRB
manufacturer’s meeting held on 06-08-2013,
specifications.
Since no one appeared on behalf of the
accused/firm before the 238th meeting of the Board
so the Board deferred the case to give final
opportunity of the personal hearing to the
firm/accused. The Board, in the same meeting,
further decided to stop production of Pamectin
Drench till final decision by the Board.

During proceeding of the 239th meeting, the Board

was informed that the orders for stoppage of the
production of Pamactin Drench, taken in its 238th

102
Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

meeting, could not be conveyed as the approval of

minutes was not received in time from members.

Mr. Ahsan Naseer Awan, Director, Nawan

Laboratories, appeared on behalf of the firm and
stated that, as per their investigation, mal
functioning of mixer lead to improper mixing
resulting in low percentage of active drug in certain
portions of the mixture. He further informed that
problem has been rectified and the sub-standard
product has been recalled.

Decision:-

The Board in view of the personal hearing and

available record of the case decided as under:-

Production of Pamectian Drench be

stopped till further orders

Inspection of the firm by the following panel

in order to indentify the problems and
confirm the actions taken by the firm:-

Director, DTL Quetta,

DDG, (E&M) Karachi.

Area FID.

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Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

2. Hydrogen Peroxide M/s. Substandard in Not challenged Samples drawn from JPMC, Karachi on 09-
Solution Batch No. Karachi respect of Acidity 07-2012 by FID Karachi-III. The firm could not
840 Pharmaceuti & Assay for provide any valid justification for non conformance
cal Hydrogen of the product in question with the specifications.
(F. No. 3-21/2012- Laboratories Peroxide: Show Cause Notices, for cancellation / suspension
Q.C) , Karachi of registration / prosecution, were issued on 07-05-
2013. Accused Licensee namely Muhammad Saleh
Assay Memon, Mrs. Amina Mehboob Ali, Mrs. Farida
Qureshi and the Firm / their representative, were
Determined: called for personal hearing before 238th DRB
3.402%w/v meeting held on 06-08-2013.

The case was deferred by the Board in its 238th

Limits: 5.0%w/v to meeting on request of Mr. M. Shaban, Regional
7.0%w/v. Manager, KPL. The Board, in the same meeting,
further decided to stop production of Hydrogen
Does not comply
Peroxide till final decision by the Board.
with BP 2011
During proceeding of 239th DRB meeting, The
Board was informed that the orders for stoppage of
the production of Hydrogen Peroxide, taken in its
238th meeting, could not be conveyed as the
approval of minutes was not received in time from
members.

Mr. Muhammad Shaban, Manager Quality

Assurance, appeared on behalf of the firm and

104
Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

submitted a written reply. As per the reply the firm

claimed to have recalled and replaced the sub-
standard stocks from the JPMC. The firm further
pointed out that a sample of the same batch, drawn
by FID from distributor of the firm, has been
declared of standard Quality by CDL. The firm’s
representative also referred to their request for
appellate testing made vide letter dated 10-09-
2012, which, as per photocopy submitted by the
firm, was received at DRAP Karachi office on 11-
09-2012.

With regards to the standard report of the same

batch issue by the CDL, the Board noted that, the
Federal Government Analyst, in this report, has
stated that quality of the bottle and sharpness,
visibility and colour of the labels text of the
sample was different from the one declared sub-
standard vide its earlier report. The Board
However, observed that appellate testing request of
the firm appears to be with in time as per
documents / evidence of the receipt submitted by
the firm.

Decision:-

The Board, in view of the personal hearing and

105
Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

available record of the case, decided as under:-

Production of Hydrogen Peroxide be

stopped till further orders

The Board’s portion of the sample

(Hydrogen peroxide Batch No 840) already
drawn from JPMC, Karachi will be sent for
appellate testing.

3. Carded Absorbent M/s Sub-Standard:- in Sub-Standard:- in Samples drawn from M/s Pharmex Fair Price Drug
Cotton Wool, National respect of respect of Store, JPMC, Karachi on 16-08-2012 by FID-III
Absorbent description:- description Karachi. The Appellate Lab, to which Sample was
Batch No. 4555-C, Cotton Mills sent on firm’s request, also declared the sample sub-
Co, Karachi Not well carded White cotton, free
F.No.3-20/2012-QC standard. Show Cause Notice, issued on 05-07-2013
cotton, not from pieces of
to the accused namely Mr.Kashif Iftikahr C.E.O,
bleached to a good thread, leaf, shell
Mr. Zahid Hussain I/C Q.C, Mr. Ilyas Khan, I/C
white, it is free and foreign matter.
Production and the Firm. The Accused Licensee /
from leaf shells & It do not offer
Representative were called for personal hearing
foreign mater, it appreciable
before 238th DRB meeting held on 06-08-2013.
does not offer any résistance when
appreciable pulled and shed Since no one appeared on behalf of the
resistance when heavy dust when accused/firm before the 238th meeting of the Board,
pulled and it does gently shaken. The so the Board deferred the case to give final
not shed any staple length of fiber opportunity of the personal hearing to the
appreciable is less than 08mm. firm/accused. The Board, in the same meeting,

106
Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

quantity of fiber (Does not comply further decided to stop production of Carded
matter when gently with revised Absorbent Cotton Wool till final decision by the
shaken. specification which Board.
states that the cotton
Does not comply wool should be well During proceeding of the 239th meeting, the Board
with the carded, should have was informed that the orders for stoppage of the
description a staple length of not production of Carded Absorbent Cotton Wool,
PC.1973 less than 08mm, taken in its 238th meeting, could not be conveyed as
should be bleached the approval of minutes was not received in time
to a good white and from members.
be odorless, should Mr. Raziuddin Ahmed, Manager and Mr. Ilyas
be free from pieces Khan, represented, National Absorbent Cotton
of thread and Mills/accused, and stated that the report of CDL
reasonable free from and Appellate Lab’s are contradictory.
leaf, shell and
foreign matter The Board observed that the report of Appellate
should offer Lab is conclusive evidence of the facts stated
appreciable therein under Section 22(5) of Drugs Act 1976.
resistance when
pulled and should Decision:-
not shed any The Board in view of the personal hearing and
appreciable quantity available record of the case decided as under:-
of dust when gently
shaken. Suspension of Registration of Carded
Absorbent Cotton Wool for three months

Inspection of the firm by the following panel

107
Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision
#

for reporting on GMP Compliance:-

Director, DTL Quetta,
DDG, (E&M) Karachi.
Area FID.

Case No.02. NEW CASES

Sr. Name of Drugs Firm CDL Report Appellate Testing Detail / Decision
No

1. (i). Normal Saline M/s Marion Sub- Standard:- Not Challenged Samples drawn from manufacturer’s premises
Injection (0.9% Laboratories on 19-03-2012 by ADC Karachi from
Sodium Chloride) , Karachi Assay for sodium
consignment meant for export.
Batch No. 0105235 Chloride:
The firm could not provide any valid
F. No. 3-15/2012- Determined
justification for non conformance of the
DDC-QC-II amount/100ml:
products in question, with the specifications.
1.023gm
Show Cause Notice were issued on 07-08-
Sated amount 2013 to the accused namely Mr. Saboor,
/100ml: 0.9gm Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
Percentage: C.E.O.
113.67%
Accused Licensee and accused were called
Limits: 95.0% to for personal hearing
105.0% Does not

108
comply Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.

The Board noted that the firm failed to give

any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.

109
 Decision:-

The Board in view of the personal

hearing and available record of the case
decided to cancel registration of
Normal Saline Injection.

(ii). Normal Saline M/s Marrion Sub- Standard:- Not Challenge Samples drawn from manufacturer’s premises
Injection (0.9% Laboratories on 19-03-2012 by ADC Karachi from
Sodium Chloride) , Karachi Assay for sodium
consignment meant for export.
Chloride:
Batch No. 0105238 The firm could not provide any valid
Determined
justification for non conformance of the
F. No. 3-15/2012- amount/100ml:
products, in question, with the specifications.
DDC-QC-II 1.006gm
Show Cause Notice were issued on 07-08-
Sated amount 2013 to the accused namely Mr. Saboor,
/100ml: 0.9gm Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
Percentage: C.E.O.
111.77%
Accused Licensee and accused were called for
Limits: 95.0% to personal hearing
105.0% Does not
comply Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only

110
 04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.

The Board noted that the firm failed to give

any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.

Decision:-

The Board in view of the personal

hearing and available record of the case
decided to cancel registration of

111
 Normal Saline Injection.

(iii). Marivell-5 M/s Marrion Sub-Standard:- Not Challenge Samples drawn from manufacturer’s premises
Injection Batch Laboratories on 19-03-2012 by ADC Karachi from
No.0205852 , Karachi In respect of
consignment meant for export.
Endotoxins Test
(Dextrose) The firm could not provide any valid
Does not comply
justification for non conformance of the
F. No. 3-15/2012-
products, in question, with the specifications.
DDC-QC-II
Show Cause Notice, were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.

Accused Licensee and accused were called for

personal hearing

Mr. Imran Saboor represented M/s Marion

Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP

112
 authorities later allowed resumption of
production after confirming that the firm has
made required improvements.

The Board noted that the firm failed to give

any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.

Decision:-

The Board in view of the personal

hearing and available record of the case
decided to cancel registration of
Marivell-5 Injection.

(iv). Marivell-5 M/s Marrion Sub-Standard:- Not Challenge Samples drawn from manufacturer’s premises
Injection Batch Laboratories on 19-03-2012 by ADC Karachi from
No.0205854 , Karachi In respect of
consignment meant for export.
Endotoxins Test
(Dextrose) The firm could not provide any valid
Does not comply
justification for non conformance of the
F. No. 3-15/2012-
products, in question, with the specifications.

113
DDC-QC-II Show Cause Notice, were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.

Accused Licensee and accused were called for

personal hearing

Mr. Imran Saboor represented M/s Marion

Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.

The Board noted that the firm failed to give

any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd meeting held on 29-30th

114
 July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.

Decision:-

The Board in view of the personal

hearing and available record of the case
decided to cancel registration of
Marivell-5 injection.

2. Aerolin Syrup M/s Ankaz Sub-Standard: Adulterated Samples drawn from manufacturer’s premises
Pharmex, on 19-07-2012 by FID Karachi-III
Batch No. 404 Karachi Assay for Remarks:-
Salbutamol: The firm requested for appellate testing
(Salbutamol) During the analysis of
Determined salbutamol Sulphate In response to Show Cause Notice the firm did
F.No.03-16/2012- amount/5ml: Syrup unidentifiable not agree with the appellate Lab’s report.
DDC QC 1.4778 mg peaks eluted alongwith
active ingredient at the Show Cause Notices, were issued on 07-08-
Stated amount/5ml: retention time of 2.48and 2013 to the accused namely Mr. Zafar Shah
2.0mg 4.803 minutes. The area Production Incharge, Mr. Jubair Ali, Quality
of these unidentifiable Control Manager and the Firm / through its
Percentage:
peaks found two times C.E.O.
73.89%
greater than the area of
Limits:- 90.0% to active ingredient Accused Licensee and accused were called for
personal hearing
105.0 % Does not

115
comply with BP Mr. Nazurl Islam, Quality Assurance Manager
2011 of Ankaz Pharmex represented the firm and
stated that the drug is of standard quality as
per test/analysis of the keeping samples by
their Q.C Department and no adulteration was
found. He further claimed that the NIH report
wrongly interpreted the eluted extra peaks as
unidentifiable which, in fact, were of
excipient.

The Boar however was of the view that the

issue needs to be thoroughly
examined/investigated

Decision:-

The Board in view of the personal hearing

and available record of the case decided as
under:-

Production of Aeroline Syrup be

stopped till further orders

Inspection of the firm by the following

panel to thoroughly investigate the
matter
Director, DTL Lahore,
DDG, (E&M) Karachi.
Area FID.

116
3. Pracmol M/s Glitz Sub-Standard Sub-Standard:- Samples drawn from manufacturer’s premises
Suspension Batch Pharma on 18-03-2013 by FID Islamabad
No. PM-28 Islamabad Assay for Assay for Paracetamol:-
Paracetamol:- The firm requested for appellate testing.
(Paracetamol) Stated:- 120mg/5ml
Determined Show Cause Notice, were issued on 07-08-
F.No. 03-22/2013- amount/5ml: Found:- 96.03mg/5ml
2013 to the accused namely Chaudhry
QC 99.264 mg Limit: 95-105% Munawar Hussain, Chief Executive Officer,
Mr. Sheikh Imran Aslam, Production
Stated amount: Percentage: 80.02%
Manager, Mr. Kiramat ullah, Quality Control
120.0 mg
Manger and the Firm / through its C.E.O.
Percentage:
Accused Licensee and accused were called for
82.72%
personal hearing
Limits:- 95.0% to
105.0% Does not Mr. Ch. Munawar Hussain, C.E, Shaikh Imran
Aslam, Prod. Manager, Kiramat ullah, Q.C
comply BP 2011
Manager, appeared before the Board and
stated that the drug is of standard quality as
per repeated test/analysis of the keeping
samples by their Q.C Department and they are
trying to find out the cause of the problem..

The Boar however was of the view that the

consistent CDL and Appellate Lab’s results
clearly indicate that the product is not up to
the specified standards.

Decision:-

The Board in view of the personal hearing

117
and available record of the case decided as
under:-

Suspend registration of Paracmol

suspension for six months.

Inspection of the firm by the following

panel to thoroughly investigate the
matter
Prof. Dr. Rafi-uz-Zaman
DDG, (E&M) Islamabad.
Area FID.

118
Case No.03: MISCELLANEOUS CASES.
Case No a. MANUFACTURE AND SALE OF SPURIOUS, SUBSTANDARD AND
ADULTERATED ISOTAB TABLETS BY M/S. EFROZE CHEMICAL
INDUSTRIES KARACHI.

In January, 2012 on receipt of reports of number of deaths / serious reaction in large

number of patients, receiving medicines from the Punjab Institute of Cardiology, the than Drug
Control Administration and Government of Punjab initiated investigation to find out facts the
case. Subsequently a foreign laboratory reported contamination of antimalarial drug
“Pyrimethamine” in samples of Isotab tablets of M/s Efroze Chemical Industries, sent by the
Punjab Government. Since at that time the subject of “Drugs and Medicines” was devolved to
the provinces under 18th Amendment, therefore, the Drug Control Administration at Federal
level could not process the matter further.

The Punjab Government, however, initiated its own independent investigation during this
period. An FIR, against M/s Efroze Pharmaceuticals, Karachi, was lodged by Punjab
Government and a Judicial Commission, headed by Judge of High Court, had also been set up by
them for carrying out detail investigation of the case.

The Provincial Quality Control Board, Punjab later, vide its order dated 01-02-2012,
reported that the samples of Tablet Isotab-20 Batch No. J-093, manufactured by M/s Efroze
Chemical industries (Pvt) Ltd., Karachi, drawn by Drug Inspector, Data Ganj Bakhsh Town
Lahore, (from stocks of the medicines retrieved from the patients (who received free medicines
from PIC Lahore), were declared to be adulterated with “Pyrimethamine”, by the Government
Analyst, Drug Testing Laboratory, Punjab. The quantity of “Pyrimethamine” determined, was
46.21 mg per tab and percentage of Isosorbide-5-mononitrate (API) was declared to be 122.8%,
whereas the official limit of active ingredient was 95-105%. The Provincial Quality Control
Board Punjab, after considering the matter recommended cancellation of Registration of Isotab
Tablet and Drug Manufacturing License of M/s Efroze Chemical Industries, Karachi vides its
ordered dated 01-02-2012.

The recommendations regarding cancellation of Drug Manufacturing License was taken

up by Central Licensing Board in its 231st meeting held on 30-01-2013, wherein the Board,
suspended Tablet Section of Efroze Pharma and ordered to launch prosecution against the

119
responsible persons of the firm. The Board further recommended to the Registration Board for
the cancellation of registration of Isotab Tablet.

The Drug Registration Board in its 237th meeting held on 26-02-2013 considered the
matter and took following decisions.
i) Registration of Isotab Tablet is suspended for one year.
ii) Show Cause Notice to be issued to the Firm( for cancellation of Drug
Registration)
iii) The case be evaluated/investigated by an Expert Committee to be constituted
by the Chairman, Policy Board

As per above decisions of the Board, the following actions have been taken.
a. Firm has been issued Show Cause Notices dated 09-04-2013
b. Registration of Isotab Tablets has been suspended vide letter dated 22nd March,
2013
c. A seven member committee headed by Prof. Dr. Tahir S. Shamsi of National
Institute of Blood Disease and Bone Marrow Transplant, has been constituted
vide letter dated 08-03-2013 to evaluate the case in detail and give its
comprehensive report and recommendations with in seven days. The CLB in its
232nd meeting directed that the Committee may be asked to finalize its report on
top priority basis preferably with in week’s time.

The report of the Committee has been received recently. The Committee, as per its TOR,
has evaluated report of Defective Drugs Inquiry Tribunal, recommendation of PQCB Punjab,
investigation of area of FID Karachi and Inspection/investigation reports of National and
International Agencies. The Committee also inspected the firm for assessing the GMP
compliance status. The report of the Committee discussed the actions taken by Federal and
Provincial Authorities against M/s Efroze Chemical Industry and its finding related to GMP
status of the firm. The excerpts of the report and remarks of the Committee is Annexed

It is further Informed that M/s Efroze Chemical Industries, also file in appeal before
appellate Board against suspension of their Tablet Section by CLB. The Appellate Board
allowed manufacturing in Tablet Section on limited scale under strict monitoring.
M/s Efroze Chemical Industry has been called for personal hearing with reference to the
Show Cause Notice issued for cancellation of registration of Isotab Tablet.
Decision:-
The Board decided to defer the case till next meeting in order to provide final opportunity
of personal hearing to M/s Efroze Chemical Industry, Karachi, failing which an ex-parte

120
decision shall be taken. In the mean time, the members may also study the report of the
Committee and come up with their recommendations/views in next meeting.

Case No b. Manufacture and Export of Sub-Standard Marivell-5 Injections by M/s

Marion Laboratories (Pvt) Karachi

The Secretary Central Licensing Board has forwarded have the following decision of the
Central Licensing Board taken in its 232 meeting held on 29-30 July,2013 for consideration of
Drug Registration Board:-

“The Board also decided to send recommendation to the Registration Board for
cancellation/suspension of registration of Injection Marivell-5 (Dextrose 5%)
500ml under Section 42 of Drugs Act, 1976 and rules framed there under for
manufacturing and supply of Sub-Standard drug in the importing country”.

M/s Marion laboratories manufactured and exported two consignments of Marivell-

5 Injection (246240 Bottles) to Rawanda via Darussalam Tanzania through M/s Royal
Groups Karachi in early 2012. The Consignments were reported to be declared sub-
Standard by Rawanda Bio Medical Center of the importing country which also
recommended for rejection of whole consignments. A dispute between M/s Marion Labs
and M/s Royal Group arose on the issues of the destructions of stocks at Darussalam and
Rawanda and compensation. Falling to settle the matters with M/s Marion, the Royal
Group approached the DRAP Authorities for support claiming that manufacture of sub-
standard drug for export by M/s Marion Lab’s has put Pakistan reputation at stake and
could seriously effects export of drugs of Pakistani origin if the dispute is not appropriately
settled. The DRAP Authorities and Central Licensing Board asked M/s Marion
Laboratories number of times to settle the matter amicably with M/s Royal particularly
regarding destruction of the Sub-Standard exported consignments lying at the port of
Darussalam and at Rawanda, in order to avoid bringing bad name to Pakistan export. M/s
Marion, however, failed to cooperate and appeared to have resorted to delaying tactics.

With regards to substandard exports, a GMP inspection of the firm was carried out
and the production of the firm remain suspended till September, 2012. Thereafter the firm
was found closed by an inspection panel which visited the firm on 11th, June 2013. The
panel formally closed production of the firm vides its inspection report dated 11-06-2013.

121
The matter was subsequently considered by the Central Licensing Board in its 232nd
meeting wherein Board took number of decision including suspension of Drug
Manufacturing License of M/s Marion Lab’s Karachi for six months.
Decision:-
The Board considered the case along with sub-standard cases of M/s Marion Laboratories
Karachi, included in the New Cases {Case No.2(1)}of the Q.C Agenda, wherein the Board
already decide to cancel the registration of Marivell-5 Injection for sub-standard
manufacturing.

Case No c: MANUFACTURE / SALE OF SUBSTANDARD MACRONIDE

INFUSIONS BY M/S MAC & RAIN PHARMACEUTICALS, LAHORE.

The Federal Inspector of Drugs on 31st May, 2011 and 4th June, 2011 drew samples of
five different batches of Macronid 100ml Infusion from the Main Medical Store, MCH and Store
of Children Hospital at PIMS. On 4th June, 2011 different batches of Macronid Infusions at Burn
Center, Store of Children Hospital and Main Store at PIMS were also ordered Not to Dispose off
for three months by the FID. The FID, Islamabad later reported that the reports of the
aforementioned samples were not received until May, 2012. On 17th May, 2012 photocopies of
two substandard test reports, number 489/2011 & 490/ 2011 dated 28-05-2011, issued in respect
of Macronid Infusion batch No. 105209 and 105208 were received. The other three batches of
Macronid Infusions i-e 104262, 105123 and 010271 were declared standard Quality as per
photocopies of reports of CD L provided by FID.

Immediately, on receipt, the two substandard reports were sent to PIMS and stocks of
substandard batches were again ordered Not to Dispose off 18(1)(i) of Drugs Act, 1976 by FID
on 21-05-2012 at Burn Center, Main Medical Store and MCH at PIMS and requested for
extension of not to dispose off period under Section 18 of the Act. The FID’s request for
extending not to dispose off orders was put up in June 2012, but file returned in April 2013,
without any action. The Federal Inspector of Drug in the mean time also called explanation of
the manufacturer M/s Mac & Rains Pharmaceuticals Lahore. The firm in response did not agree
with the repots and stated that one of batch of Macronid Infusion (No 105208) was already
declared standard by DTL, Punjab and further stated that the direct temperature shock applied on

122
the bottle during sealing (remarks of Federal Government Analyst) has compromised the sterility
of the product.

The Federal Inspector of Drugs is of the view that the same method of seal was applied to
all the other sample of Mecronid Infusion sent to Central Drug Laboratory and the reports of
other three batches of the product, wherein the thermal shock was also reported by the Federal
Government Analysis, were of standard quality and the firm’s contention therefore is not valid.
The Federal Inspector of Drugs, therefore, concluded that the firms has violated the section (23)
(1) (a) (V), of Drug Act 1976.

Decision:-

The Board, in view of the available record and facts of the case, decided as under:-
Show Cause Notice be issued to the firm and responsible persons.
FID may be advised to pass not to dispose off orders/make seizure, which ever is
applicable, for the sub-standard stocks at PIMS.
Initiate recall proceedings for sub-standard stocks if supplied in the market

123
 Item No.V Any Other Item with permission of chair

Registraion-I
Case No: 01. Aplications for registration (locally manufactured Veterinary drugs (me-
too/new drugs) for fast track.

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision

Applicant Size Life
1. M/s. Mylab (Pvt) Nemasol Plus Drench Decontrolled 02 Approved
Ltd. Khanqah Each ml contains:- 150ml years
Sharif, Levamizole …………..15mg 500ml
Bahawalpur. Oxyclozanide………..30 mg 1000ml
Cobalt Sulphate ...…1.67 mg 5 Litre
Sodium Selenite ..….0.50mg 10 Litre

2. M/s. Mylab (Pvt) Hepanol Oral Solution Decontrolled 02 Deferred for

Ltd. Khanqah Each 100ml contains:- 100ml years application on
Sharif, Sorbitol …………...….35gm 250ml Form 5 D along
Bahawalpur. Acetyl Metionine …….10gm 500ml with revised Fee
Choline HCL ……….7.5 gm 1000ml and comments of
Betain …………….6.0 gm following experts;
Lysine Hydrochloride .2.0gm 1. Dr. M
Ashraf,
UVAS
2. Head of
Pharmacolog
y Deptt.
UAF
3. Dr. M.
Arshad,
Member
DRB.
3. M/s. Mylab (Pvt) Imnate Injection Decontrolled 02 Approved
Ltd. Khanqah Each ml contains:- 10ml years
Sharif, Imidocarb 20ml
Bahawalpur. Dipropionate………120mg 50ml
100ml
4. M/s. Mylab (Pvt) Melodyl Injection Decontrolled 02 Deferred for
Ltd. Khanqah Each 100ml contains:- 10ml years application on
Sharif, Cyanocobalamine …0.05mg 20ml Form 5 D along
Bahawalpur. Sodium Selinite ……100 mg 50ml with revised Fee
Adenosine Triphosphate 100ml and comments of
Tetrasodium following experts;
Trihydrate……………0.1gm a. Dr. M Ashraf,
Potassium Aspartate Semihydrate UVAS
…………1.0gm b. Head of
Magnesium Aspartate Pharmacology

124
 Tetrahydrate ……….1.5gm Deptt. UAF
c. Dr. M.
Arshad,
Member DRB
5. M/s. Mylab (Pvt) Rivaflor 300 Injection Decontrolled 02 Approved
Ltd. Khanqah Each ml contains:- 10ml years
Sharif, Florfenicol ………...300mg 20ml
Bahawalpur. 50ml
100ml
6. M/s. Mylab (Pvt) Terralon 50 Injection Decontrolled 02 Approved
Ltd. Khanqah Each ml contains:- 10ml years
Sharif, Oxytetracycline ……50mg 20ml
Bahawalpur.

7. M/s. Mylab (Pvt) Tetrasol Injection Decontrolled 02 Deferred for

Ltd. Khanqah Each ml contains:- 100ml years application on
Sharif, Chlortetracycline.2.45% w/w Form 5 D along
Bahawalpur. (Antibiotic) with revised Fee
and comments of
following experts;
a. Dr. M Ashraf,
UVAS
b. Head of
Pharmacology
Deptt. UAF
c. Dr. M.
Arshad,
Member DRB
8. M/s. Mylab (Pvt) Xylax Injection. Decontrolled 2 years Approved
Ltd. Khanqah Each ml contains:- 5ml
Sharif, Xylazine HCl 23.32mg. 10ml
Bahawalpur. (Analgesic, Sedative). 20ml
25ml
30ml
50ml
100ml
9. M/s. Mylab (Pvt) Duretic Injection. Decontrolled 2 years Approved
Ltd. Khanqah Each ml contains:- 5ml
Sharif, Furosemide………50mg. 10ml
Bahawalpur. (Diuretic). 20ml
30ml
50ml
100ml
10. M/s. Mylab (Pvt) Vantix Solution Decontrolled 03 Deferred for
Ltd. Khanqah Each 100ml contains:- 100ml years application on Form
Sharif, Fipronil……….0.25gm 250ml 5 D along with
Bahawalpur. (Disinfectant). 500ml revised Fee and
comments of
1000ml
following experts;
a. Dr. M Ashraf,
UVAS

125
 b. Head of
Pharmacology
Deptt. UAF
c. Dr. M. Arshad,
Member DRB
11. M/s. Baariq Zoleriq 10% Oral Drench Decontrolled 02 Approved
Pharmaceuticals, Each ml oral drench contains:- 100ml years
Raiwind Road, Albendazole……100mg 250ml
Lahore. (Benzimidazole). 500ml
1000ml
12. M/s. Baariq Oxfendaox Plus Oral Drench Decontrolled 02 Approved
Pharmaceuticals, Each ml contains:- 100ml years
Raiwind Road, Oxyclozanide ……..62.50mg 500ml
Lahore. Oxfendazole …………22.65 1000ml
Cobalt Sulphate……1.67mg 2500ml
Sodium Selenite…….0.50mg
(Salicylanilide, Benzimodazole,
Trace Elements).
13. M/s. Baariq Zolesel-CS Oral Drench Decontrolled 02 Approved
Pharmaceuticals, Each ml contains:- 100ml years
Raiwind Road, Albendazole……….50mg 500ml
Lahore. Cobalt Sulphate……3.82mg 1000ml
Sodium Selenite……0.35mg 2500ml
(Benzimodazole, Trace Elements).
14. M/s. Baariq Levoxbar-Plus Drench Decontrolled 03 Approved
Pharmaceuticals, Each ml contains:- 100ml years
Raiwind Road, Levamisole HCL..15mg 150ml
Lahore. Cobalt Sulphate…1.67mg 500ml
Oxyclozanide…………30mg 1000ml
Sodium Selenite……0.50mg 2500ml
(Salicylanilide, Trace Elements).

15. M/s. Baariq Levacob-SS Oral Drench Decontrolled 03 Approved

Pharmaceuticals, Each ml contains:- 100ml years
Raiwind Road, Levamisole HCL……15mg 500ml
Lahore. Cobalt Sulphate……3.82mg 1000ml
Sodium Selenite…….0.50mg 2500ml
(Salicylanilide, Trace Elements).
16. M/s. Baariq Amantadox-T Water Soluble Decontrolled 02 Approved
Pharmaceuticals, Powder 100gm years
Raiwind Road, Each 1000 gm powder contains:- 250gm
Lahore. Tylosin Tartrate 500gm
…….100gm 1000gm
Doxycyline HCL……200gm 2500gm
Amantadine HCl…….45gm 5000gm
(Antibiotic)
17. M/s. Baariq Colibect Water Soluble Powder Decontrolled 02 Approved
Pharmaceuticals, Each 100gm powder contains:- 100gm years
Raiwind Road, Colistin Sulphate…500,000,000 IU 250gm
Lahore. (Antibiotic, Antibacterial). 500gm
1Kg

126
 2.5Kg
5Kg
10Kg
25Kg
18. M/s. D-Maarson LEVANIDE-CS Suspension Decontrolled 02 Approved, with
Pharmaceuticals, Each 100ml contains:- 100ml years Brand Name
Rawat, Islamabad. Oxyclozanide…….3.0g 150ml change
Levamisole HCl …1.5g 250ml
Cobalt Sulphate ….0.382% 400ml
500ml
1Litre
2.5Litre
25 Litre

19. M/s. D-Maarson ALBENMARS Suspension Decontrolled 02 Approved

Pharmaceuticals, Each 100ml contains:- 100ml years
Rawat, Islamabad. Albendazole…….2.5g 150ml
Sodium selenite ...0.035% 250ml
Cobalt chloride …0.075% 400ml
500ml
1Litre
2.5Litre
25 Litre
20. M/s. D-Maarson LEVAMARS Suspension Decontrolled 02 Approved
Pharmaceuticals, Each 100ml contains:- 100ml years
Rawat, Islamabad. Levamisole HCl …1.5% 150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre

21. M/s. D-Maarson TOLTRA MARS Liquid Decontrolled 02 Approved, with

Pharmaceuticals, Each 1000ml contains:- 100ml years Brand Name
Rawat, Islamabad. Toltrazuril …..25g 250ml change
Vitamin K3 …3g 500ml
1Litre
2.5Litre
22. M/s. D-Maarson FENMARS Suspension Decontrolled 02 Approved
Pharmaceuticals, Each ml contains:- 100ml years
Rawat, Islamabad. Oxfendazole … 22.65mg 150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre
23. M/s. Medi-Vet Floxivet-Col + Oral Solution Decontrolled 02 Deferred as
(Pvt) Limited, Each 100ml contains:- 100ml years production of firm

127
 Lahore. Enrofloxacin HCI 250ml has been stopped
CP………………..10.0gm 500ml by CLB
Amantadine HCI 1000ml
BP………………..04.0gm
Colistin Sulphate
BP…......................3.5gm
(Antibiotic/Antibacterial/Antiviral).
24. M/s. Medi-Vet Floxivet-C Injection Decontrolled 02 -Do-
(Pvt) Limited, Each ml contains:- 100ml years
Lahore. Enrofloxacin B.P Vet…100mg/ml 250ml
Colistin Sulphate BP..250000 iu/ml 500ml
(Antibiotic/Antibacterial). 1000ml

25. M/s. Medi-Vet Amcol-Vet Oral Suspension Decontrolled 03 Rejected as firm

(Pvt) Limited, Each 100ml contains:- 100ml years does not have the
Lahore. Amoxicillin base (as 250ml separate Penicillin
Trihydrate……..B.P…15gm 500ml Section.
Colistin Sulphate B.P…..50 MIU 1000ml
(Antibiotic/Antibacterial).

26. M/s. Medi-Vet Medi-Voc Injection Decontrolled 02 Deferred as

(Pvt) Limited, Each ml contains:- 100ml years production of firm
Lahore. Ivermectin B.P………..10mg 250ml has been stopped
(Dewormer/ Anthelmintic). 500ml by CLB
1000ml

27. M/s. Medi-Vet Medi-Dox Plus Solution Decontrolled 02 -Do-

(Pvt) Limited, Each 100ml contains:- 100ml years
Lahore. Tylosine Tartrate B.P 500 ml
Vet………………..10gm 1000ml
Doxycycline HCI
B.P……………….20gm
Colistin SulphateB.P…….500,000
IU
Bromhexine HCI
B.P…………………500mg
(Antibiotic/Antibacterial).

128
Case No.2: Change of formulation of already approved veterinary drugs.

M/s. D-Maarson Pharmaceuticals, Islamabad have requested for change of formulation of

their already approved veterinary drugs by the Drug Registration Board in its 237 th meeting held
on 26-02-2013. The registration letters of the drugs have not been issued so far due to new
formulation. Now the firm has requested for change of formulation as per already approved
drugs:-
S.No. Existing Formulation. New Formulation.
1. Col-Plus Oral Liquid Col-Plus Oral Liquid
Each 100 ml contains:- Each 100 ml contains:-
Florfenicol……15gm. Florfenicol…… 20gm
Colistin Sulphate … 50 MIU
2. Coli En Liquid. Coli En Liquid.
Each 100ml contains:- Each 100ml contains:-
Enrofloxacin ……10gm. Enrofloxacin ……..20gm
Colistin sulphate…. 55 MIU Colistin sulphate …50 MIU

Decision: Request of the firm was acceded by the Board.

Case No.3: Change of manufacturing site of registered imported drug

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change
of manufacturing site of their registered imported drug namely “Galvus Tablets 50mg (Reg.
No.059038)” from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis
Farmaceutica S.A., Spain.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have deposited required fee
Rs.50000/= (Pages 44-45/Corr) and submitted following supporting documents:-

i) Copy of registration letter.

ii) Original legalized EMA CPP of new manufacturing site.
iii) Copy of NOC for CRF.
iv) Registration of the drug is valid.

Decision:
The board after detailed discussion approved the change in manufacturing site of
Galvus Tablets from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis

129
Farmaceutica S.A., Spain. The Board advised to deposit balance fee as per revised fee
schedule and site master file of new manufacturing site.

Registration-II
Case No.4 Deferred cases.

a. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi

Following product of M/s Adamjee Pharmaceuticals, Karachi was deferred for review the
case after submission of balance fee, GMP of source, COA and stability data by the Expert
Committee of Registration Board in its 237th meeting.

Name of Drug & Composition Pack size Demanded

MRP

Papazole Capsule 2x7’s As Per SRO

Each capsule contains:-
Pantoprazole sodium sesquihydrate
equivalent to Pantoprazole…………….40mg
(Selective inhibitor of Cyclic Guanosine
Monophosphate)

Now the firm has requisite information as under:-

i) Pantoprazole Pellets will be import from M/s Glukem Pharmaceuticals (Pvt.) Ltd,
Plot No. 205/2A, First Floor, IDA, Phase-II, Cherlapally, Hyderabad, Andhra
Pradesh, India

ii) GMP Certificate of bulk import source issued on 23-07-2012 valid for one year.

iii) Certificate of Analysis

iv) Stability data (Accelerated i.e 400C / 75% RH and long term studies i.e 250C /
65% RH)
v) Balance fee Rs.240,000/-

Decsion: Regsitartion Board approved firm’s request. However, the Borad advised to
provide valid GMP certicate or identify another manufacturer and submit its relevant
documents and authorized its Chairman to accord approval for issuance of regiatration
letter.
130
 b) M/s Abbott Laboratories, Karachi

The Registration Board in 237th meeting deferred registration of following drug of M/s
Abbott Laboratories, Karachi reason mentioned in last column.
S. Name of drug(s) & Proposed Demanded Date of Decision
No Composition Price application,
Pack size Diary No.
& Form

1 Klaricid-DS Granules 60ml Rs.630/- 16-06-2011 Sub-Committee

decided to review
Each 5ml contains: Dy.No.1601
the case after
Clarithromycin 250 mg Form-5 submission of
balance fee, GMP
Rs.8000/-
(Antibiotics) of source, COA and
Rs.12000/- stability data
12-10-2012
Rs.40,000/-
29-1-2013

M/s Abbott Labs, Karachi has now furnished the following documents:-
i) GMP Certificate of API source M/s Ranbaxy Laboratories Ltd, Industrial Area
No.3 A.B. Road, Dewas 455 001 (MP), India issued on 15-02-2013 valid till 15-
01-2015.

ii) Certificate of Analysis

iii) Stability data (only long term studies for 36 months at 250C / 60% RH)
iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decsion: Regsitartion Board approved Klaricid-DS Granules for registration

with source of pellets mentioned above.

c) M/s PharmEvo (Pvt.) Ltd, Karachi

The Registration Board in 227th meeting deferred following product of M/s PharmEvo
Pakistan, Karachi

131
 Name of drug(s) & Proposed Demanded Decision
Composition Price
Pack size

Acrova Tablet 7’s Rs.1200.00 Deferred for

confirmation of
Each tablet contains:- 14’s Rs.2400.00 formulation
Rivaroxaban ……..10mg

(Anti thrombotic agent)

Later on scrutiny of registration data reveals that the above formulation is already
approved in 238th meeting of Registration Board for M/s Getz Pharma, Karachi under the brand
name “Xalto Tablets 10mg”.

Decsion: Regsitartion Board approved Acrova Tablet for registration.

d) Pharmatec Pakistan (Pvt.) Ltd, Karachi.

Following product of M/s Pharmatec Pakistan, Karachi was deferred, for submission of
application of Form-5D with balance fee, by the Expert Committee of Registration Board in its
237th meeting.
Name of Drug & Composition Pack size Demanded
MRP

Maltofer Fol Syrup 150ml As per PRC

Each 5ml contains:
Iron as iron (III) hydro oxide
ploymaltose………..….100 mg
Folic acid…………….400 mcg
(Supplementation and treatment of ID and
IDA)

Now the firm has furnished registration application on Form-5D along with remaining fee
Rs.90,000/-. The firm has also submitted the justification for the proposed syrup dosage form
that it has better compliance and tolerability.

132
 Decision: Registration Board deferred request for PSI by Director DTL, Karachi and
area FID. Moreover, case will be referred to Head, dept of Gynacology, FGSH, PIMS and
RGH.
e) M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi

The firm M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi had applied for the
registration of the below mentioned formulation, which was considered in the 237th meeting of
the Registration Board and deferred for reason recorded in the last column:

S. Name of Name of drug(s) Decision

No. applicant(s)

1. M/s Amarant Cycline 250mg Capsule Deferred for

Pharmaceuticals , confirmation of
Karachi Each capsule contains: manufacturing
facility.
Cycloserine……250mg
(A broad spectrum
antibiotic)

Now the firm has submitted that they have the facility for manufacture of the said
formulation i.e., Capsule (General) section and that a number of firms are manufacturing the
same product in Capsule (General) section.
Decision: Registration Board approved Cycline 250mg Capsule for registration.

f) M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, Karachi

The Registration Board in its 229th meeting deferred following products of

M/s Pakistan Pharmaceutical Products, Karachi for the reasons mentioned in last column.

S. Name of drug(s) & Formulation Pack MRP Reason

No. size

1. Pilot Suspension 125mg/5ml Rs.11.25 / Deferred for panel

inspection to

133
 Each 5ml contains:- 5ml evaluate GMP
compliance & track
Cefadroxil ………….….125mg
record
(Antibiotics)

2. Pilot Suspension 250mg/5ml Rs.20.83 / -do-

5ml
Each 5ml contains:-
Cefadroxil …………….250mg
(Antibiotics)

3. Pilot Capsule 500mg Rs.25.75 -do-

Each capsule contains:- (Per

capsule)
Cefadroxil …………...500mg

(Antibiotics)

Now, the firm has submitted product specific inspection report dated 28-02-2011 of panel
constituted by the Registration Board in its 227th meeting and routine GMP inspection dated 13-
02-2013 conducted by the area FID. Where the FID has mentioned in inspection report that firm
has concerned Cephalosporin Oral Dry Syrup and Capsule Sections and concluded as follows:-
“ based on the areas inspected, the people met and the documents
reviewed , and considering the findings of the inspection of M/s Pakistan
Pharmaceutical Products, site was considered to be operating at good
level of compliance with GMP guidelines as per Drugs Act, 1976 and
rules framed there under”
Decision: Registration Board deferred request for PSI by Director DTL, Karachi and
area FID.

g) M/s Aventis Pharma, Karachi – Claforan 2.0gm Injection

The Registration Board in 237th meeting deferred following application of M/s Aventis
Pharma, Karachi for reason recorded in last column.
Name of drug(s) & Proposed Demanded Date of Decision
Composition Price application,
Pack size Diary No.

134
 & Form

Claforan 2.0g Injection Per vial Rs.550.43 19-05-2011 Deferred for

approval by
Each vial contains:- 1257 USFDA, EMA,
regulatory body of
Cefotaxime as Form-5
Japan & Australia.
Sodium ….2gm Rs.8000/-
(Antibiotics) Rs.72,000/-
29-1-2013

Now the firm has submitted that the above formulation is already registered for several firms
including M/s Alina Combine, Karachi under the brand name “ Hexime Injection 2gm” Reg.
No.012814 and M/s P.D.H Pharmaceuticals, Karachi under the brand name of “Cephronate
Injection” Reg. No.019699. The said formulation has also been approved by USFDA, MHRA &
Regulatory Body of Australia.

Decision: Registration Board approved Claforan 2.0g Injection for regsitration.

h) M/s Macter International, Karachi
The Registration Board in 237th meeting deferred registration of following drug of M/s
Macter International, Karachi reason mentioned in last column.
S. Name of drug(s) & Proposed Demanded Date of Decision
No Composition Price application,
Pack size Diary No.
& Form

1 Itoguard OD 150mg 10’s Rs.33/- 06-09-2012 The Sub-

Capsule Committee decided
14’s Per Cap. 1515 to review the case
Each capsule contains: after submission of
20’s Form-5
Itopride hydrochloride balance fee, GMP
(as sustained release 30’s Rs.8000/- of source, COA and
pellets)……….150 mg stability data
Rs.52,000/-
(Gastro kinetic) 23-1-2013

M/s Macter International, Karachi have now furnished the following documents:-
i) Certificate of Analysis

135
 ii) Comparative Dissolution Method

iii) GMP Certificate of source M/s Spansules Formulation, India

iv) Stability study data

v) Fee Rs. 300,000/- for the purpose.

Decision: Registration Board approved Itoguard OD 150mg Capsule for regsitration.

i) M/s Amarant Pharmaceuticals, Karachi

The Registration Board in 228th meeting deferred for expert opinion the registration of
following drug of M/s Amarant Pharmaceuticals, Karachi
S. Name of drug(s) & Composition Proposed Demanded
No Price
Pack size

1 Amprexa-F Capsules 6/25mg As per As per SRO

SRO
Each capsule contains:-
Olanzapine …………..…6mg
Fluoxetine HCl ……….25mg

Later on scrutiny of registration data reveals that the above formulation is already registered for
M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.
No.073778.
Decision: Registration Board approved Amprexa-F Capsules 6/25mg for regsitration.

j) M/s Nabiqasim Industries, Karachi

The Registration Board in 237th meeting deferred for confirmation of Me-Too status the
registration of following drug of M/s Nabiqasim Industries, Karachi
S. Name of drug(s) & Composition Proposed Demanded
No Price
Pack size

1 Co-Dep 6/25 Capsule 10’s As per PRC

136
 Each capsule contains: 14’s

Olanzapine ……………6 mg 20’s

Fluoxetine HCl………..25 mg 30’s

(Anti psychotropic)

2 Co-Dep 3/25 Capsule 10’s As per PRC

Each capsule contains: 14’s

Olanzapine ……………3 mg 20’s

Fluoxetine HCl………..25 mg 30’s

(Anti psychotropic)

Later on scrutiny of registration data reveals that the above formulation is already registered for
M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.
No.073778 & Lanzif 3/25mg Capsule, Reg. No.073777

Decision: Registration Board approved above products for regsitration.

Case No.3 BULK IMPORT AND LOCAL REPACKING – M/S

GLAXOSMITHKLINE PAKISTAN LTD, KARACHI

M/s GlaxoSmithKline Pakistan Ltd, Karachi has requested for grant of permission for
bulk import from parent UK source and local repacking in limited quantity i.e 04 million tablets
in divided shipments of Zinacef 250mg, Reg. No.011340 containing Cefuroxime to avoid any
shortages in local market due to extension and renovation of their Cephalosporin facility at
Korangi Factory (DML No.000248).

Firm has also deposited fee Rs.100,000/- for the purpose.

Decision:
Registration Board deferred firm’s request and advised to provide following
documents for decision:
a. Renovation plan with time lines duly approved by manitenace department of the
firm and confirmation by licensing section, DRAP.
b. Manufacturing status of other products in same section.

137
 c. Legalized COPP for proposed manufacturer.
d. Form 5.

Case No.4 Change of Formulation

a) M/s Noa Hemis Pharmaceuticals, Karachi

M/s Noa Hemis Pharmaceuticals, Karachi has requested for change of formulation of
following registered drug. Existing and proposed formulations are as under.

S. Reg. Previous formulation Proposed formulation

No No.

01 032179 Mucof Syrup Mucof Syrup

Each 100ml contains:- Each 5ml contains:-
Ephedrine HCl …………...100mg Chlorpheniramine Maleate…5mg
Chlorpheniramine Maleate.100mg
Terpinhydrate…………….10mg
Terpinhydrate…………….200mg
Pot. Bicarbonate ………...0.1mg
Pot. Bicarbonate …………...2mg
Ammonium Chloride…….25mg
Ammonium Chloride…….500mg
Menthol …………………..1mg
Tr. Senega ………………..1.0ml
Aminophylline Ph Eur …….32mg
Menthol …………………..20mg
Pot. Guaicol Sulph ……….5mg
Bromhexine HCl ………….20mg
Pot. Guaicol Sulph ……….100mg Pot. Citrate ………………..0.1mg

Pot. Citras ………………..…2mg Flavour & Base ……………q.s

Tr. Ipecac …………………0.5ml

Ext. Glycyrrhiza Liq. ……….2ml

Firm has submitted that proposed formulation is already registered in fvaour of M/s CCL
Pharmaceuticals, Lahore i.e Pulmonol Syrup, Reg. No.000874. Firm has also furnished new
form-5 along with requisite fee Rs.20,000/- for the purpose.

138
Decsion: Registration Board deferred firm’s request for PSI by Director DTL,
Karachi and DDG (E&M), Karachi.

Case No.5 Registration for export purpose containing controlled drugs

M/s Amarant Pharmaceuticals, Karachi and M/s Pharmatec Pakistan, Karachi has
requested for registration of following drugs for export purpose only:-
S. No. Name of Name of drug(s) & Composition
Manufacturer(s)

1 M/s Amarant Amalor-D Tablet

Pharma, Karachi
Each tablet contains:-
Loratadine ……………..5mg
Pseudoephedrine HCl ….60mg

2 M/s Pharmatec Flu-Gone Day and Night Capsule (Combi Pack)

Pakistan, Karachi
Each combi pack contains:-

Each day-time capsule contains:- (Strip-1)

Paracetamol ……………….400mg
Psedoephedrine HCl …….. 30mg
Caffeine Anhydrous ………30mg

Each night-time capsule contains:- (Strip-2)

Paracetamol ……………….400mg
Psedoephedrine HCl …….. 30mg
Cetirizine (as Dihydrochloride)..10mg
Dextramethorphan HBr ……..10mg

139
Decision: Committee on allocation of controlled Drug has already conveyed that
Registration Board may take decision according to its rules. Thus Board approved firm’s
request. Matter regarding allocation of quota will be dealt by Committee on allocation of
controlled Drug accordingly.

Case No. 6 De-Registration of registered drugs.

Following manufacturers have requested for de-registration of their registered drugs.
Details are as under:-
S. Name of Reg. No. Name of drug(s) Reason /
No. applicant(s) Justification

1. M/s Bosch Pharma, 050507 Telocin 400mg Tablet Not interested

Karachi in
Each film coated tablet manufacturing
contains: and marketing
Telithromycin……400mg

2. -do- 030606 Arbel 50 tablets -do-

Each tablet contains:-
Losartan Potassium
…50mg

3. M/s Tabros 004088 Paracetamol Compound Not mentioned

Pharma, Karachi Tablets
(Paracetamol + Aspirin)

4. -do- 004175 Sulphadiazine Tablets -do-

(Sulphadiazine)

5 -do- 004173 Sulphadimidine Tablets -do-

(Sulphadiamidine)

Decsion: Registration Board de-registered above products. However, the Board

advised firm to provide undertaking for not pending any case at any forum.

140
Case No.7 Request for withdrawal of registration application – M/s AsianContinental
(Pvt.) Ltd, Karachi
M/s AsianContinental (Pvt.) Ltd, Karachi has requested for withdrawal of their
registration application i.e Extrac Plus Tablets, containing Clopidogrel …75mg +
Aspirin…..75mg submitted on August, 2010.
Decsion: Registration Board approved firm’s request for withdrawl of above
regsitartion application (Extrac Plus Tablets).

Case No.8 Correction in minutes

a) M/s High-Q, Karachi

Following product of M/s High-Q, Karachi was considered in the 236th meeting of the
Registration Board.

Pirokeu 20mg tablet

Each tablet contains:
Piroxicam Betacyclodextrin eq. to Piroxicam ….. 20mg
(NSAID)

The aforementioned registration application was referred to the committee comprising

Prof. Dr. Rafi-uz-Zaman Saeed-ul-Haq, Member Registration Board, DDC (Reg-II), and DDG
Reg. However, in the minutes of the said subcommittee meeting, the above mentioned product
was erroneously approved as “Piroxicam 20 mg tablet” instead of “Piroxicam Betacyclodextrin
20mg tablet” and the registration letter has not been issued. The firm has now requested that the
registration may be granted with the correct formulation.

Decsion: Request of firm for correction as Piroxicam Betacyclodextrin 20mg

tablet approved by the Board.

b) M/s Getz Pharma, Karachi

The Registration Board in its 238th meeting had considered registration application file in
Month of May & June, 2010. However, the following registration application of M/s Getz
Pharma, Karachi was erroneously not included in Agenda of 238th meeting. Details of the case
are as under:-

141
S. No. Date of Remarks
Name of drug(s) & Proposed Demanded application,
Composition Pack size Price Diary No. &
Form
1. Trizid MR Tablets 35mg Comparative
19/05/2010
Each film coated tablet dissolution
Dy. No. 1013
contains:- profile with
20’s Rs.300.00 Form 5
Trimetazidine originator
30’s Rs.450.00 Rs. 8000/-
Dihydrochloride……35mg brand and
Rs.12,000
(Anti-anginal) related
20-2--2013
documents

Decsion: Registration Board deferred firm’s request for submission of comparative

dissolution profile with brand leader.

Case No.9 Transfer of registration from import to local toll manufacturing

M/s High-Q International, Karachi has informed that following drugs are registered for
import in finished form. Now they have intend to transfer the registration from import to local
manufacturing under contract manufacturing arrangements as mentioned against each. Details
are as under:-
S. Reg. Name of Drug(s) Existing Import Proposed Contract
No. No. Manufacturer(s) Manufacturer (s)
1 045616 Ruling Injection 40mg M/s Hainan M/s Nabiqasim
Each vial contains:- Lingkang Industries, Karachi
Omeprazole Pharmaceutical Co.,
(as Sodium) ….40mg Ltd., China

(Bulk Import and

Local repacking)

2 018501 Remethan Injection M/s Shin Poong M/s Surge Labs,

75mg Pharmaceutical Co Sheikhupura
Each 3ml contains:- Ltd, Seoul Korea
Diclofenac
Sodium………….75mg

3 019467 Cycin 100mg / 50ml M/s Shin Poong M/s Surge Labs,
Injection I.V/ I.M Pharmaceutical Co Sheikhupura
Each vial contains:- Ltd, Seoul Korea
Ciprofloxacin ..100mg

4 019468 Cycin 200mg/100ml M/s Shin Poong M/s Surge Labs,

142
 Injection I.V/ I.M Pharmaceutical Co Sheikhupura
Each vial contains:- Ltd, Seoul Korea
Ciprofloxacin ..200mg

5 022645 Hizone Injection M/s Shin Poong M/s Surge Labs,

250mg IM Pharmaceutical Co Sheikhupura
Each vial contains:- Ltd, Seoul Korea
Ceftriaxone as
Sodium………250mg (Bulk import and
local repacking)

6 018300 Hizone Injection 1gm M/s Shin Poong M/s Surge Labs,
IV Pharmaceutical Co Sheikhupura
Each vial contains:- Ltd, Seoul Korea
Ceftriaxone as
Sodium………1gm (Bulk import and
local repacking)

7 014947 Cefapezone Injection M/s Shin Poong M/s Surge Labs,

1gm Pharmaceutical Co Sheikhupura
Each vial contains:- Ltd, Seoul Korea
Cefoperazone
Sodium………..1gm (Bulk import and
local repacking)
8 015589 Fugacin Tablets M/s Shin Poong M/s High-Q
Each film coated tablet Pharmaceutical Co Pharmaceuticals,
contains:- Ltd, Seoul Korea Karachi
Ofloxacin ……..200mg
9 019522 Cycin 500mg Tablets M/s IL Dong M/s High-Q
Each tablet contains:- Pharmaceutical Co. Pharmaceuticals,
Ciprofloxacin Ltd, Korea Karachi
HCl………… 500mg
10 019523 Cycin 250mg Tablets M/s IL Dong M/s High-Q
Each tablet contains:- Pharmaceutical Co. Pharmaceuticals,
Ciprofloxacin Ltd, Korea Karachi
HCl………… 250mg

Firm has furnished following information to support their request.

 Registration dossier on Form -5.

 Original consent of M/s Nabiqasim Industries (Pvt.) Ltd, Karachi (page12/Corr) and M/s
Surge Laboratories, Sheikhupura & M/s High-Q Pharmaceuticals, Karachi

143
  Contract manufacturing agreement with M/s Nabiqasim Industries (Pvt.) Ltd, Karachi
and M/s Surge Laboratories, Sheikhupura (page 26/Corr) & M/s High-Q
Pharmaceuticals, Karachi

 Copy of Registration letters & Renewal

 Fee of Rs.50,000/- for each product for the purpose.

Decision: Registration Board deferred firm’s request till next meeting for detailed
delibrations in light of contract manufacturing policy.

Case No.10 Extension in contract manufacturing permission.

The Registration Board in its 238th meeting had considered case for extension in contract
manufacturing permissions. However, the following case of M/s Sami Pharmaceuticals, Karachi
was erroneously not included in Agenda of 238th meeting. Details of the case are as under:-
S. Applicant Contract Reg. No. Name of drug(s) & Date of Category
No. manufactur Composition applicatio
er n, Diary
No. &
Form
1. M/s Sami M/s 037541 Oroxim 100mg Film 15-04- Dedicated
Pharma, Healthek Coated Tablets 2013 facility
Karachi Pvt. Karachi Each film coated Dy.No.13 Cephalosp
tablet contains: 5 orin
Cefpodoxime proxetil Form-05
eq. to Rs.50,000/
cefpodoxime..100 mg -

Decsion: Registration Board extended above product till 30.06.2015.

144
 Case No.11: Fast track registration scrutinized by evaluators.

S.N Name of Name of drug with Pack Demande Date Remarks

o manufacturer composition size d price
1. M/s. Valiant-M Tablets’ 10’s As Per 24-4- Recommended
Ferozsons Labs, Each film coated tablet 30’s SRO 2013
Nowshera contains:-
Vildagliptin………….50
mg
Metformin HCl…..850
mg
(Ant-diabetic)

2. -do- Valiant-M Tablets’ 10’s As Per -do- Recommended

Each film coated tablet 30’s SRO
contains:-
Vildagliptin……………
…….50 mg
Metformin
HCl………...1000 mg
(Ant-diabetic)
3. M/s. Winbrain Cefwell 250mg Injection Per As Per 22-5- The products are
Research IM Vial SRO 2013 recommended
Laboratories, Each vial contains:- if manufacturer is
Hattar Ceftriaxone Sodium already producing
Toll ≡ the same drugs as
manufactured Ceftriaxone………..250 it is an
by M/s. mg application of toll
Weather Fold (Anti-infective) manufacturing
Pharmaceutical, and not
Hattar manufacturing by
M/s. Winbrain.
Note:- Weather
Fold is already
having approved
section for
production of
Cephalosporin
Injection and
registered
product as well.
4. -do- Cefwell 500mg Injection Per As Per -do- -do-
IM Vial SRO
Each vial contains:-
Ceftriaxone Sodium

145
 ≡
Ceftriaxone………..500
mg
(Anti-infective)
5. -do- Cefwell 1gm Injection Per As Per -do- -do-
IM Vial SRO
Each vial contains:-
Ceftriaxone Sodium
≡
Ceftriaxone………..1gm
(Anti-infective)
6. M/s. Shazeb Zeesol-5% I.V Infusion 100ml As Per 13-5-2013 No Batch Size
Pharmaceutical Each 100ml contains:- SRO description
s, Distt Dextrose Anhyrous……..5 Batch cycle
Haripur gm Sterilization
(Caloric solution) Cycle
Source of Raw
Materials
Testing of Raw
Materials
Price Paper /
Comparison of
Dextrose 5%
Not
recommended.
Shortcoming
rectified
7. -do- Zeesol-NS O.V Solution 100ml As Per -do- No Batch Size
Each 100ml contains:- SRO description
Sodium Batch cycle
chloride……….0.9 gm Sterilization
(Electrolyte) Cycle
Source of Raw
Materials
Testing of Raw
Materials
Price Paper /
Comparison of
Dextrose 5%
Not
recommended.
Shortcoming
rectified
8. -do- Zee Hesta 3% 500ml As Per -do- Check
Each 1000ml contains:- SRO Hydroxyethyl

146
 Hydroxyethyl Standards
Starch………30 gm Not
Sodium recommended.
Chloride…….……9 gm Shortcoming
(Plasma Substitute) rectified
9. -do- Zee Haemagel I.V 500ml As Per -do- Not
Infusion SRO recommended.
Each 1000ml contains:- The firm has
Degraded gelatin informed that they
Polygeline) of average can’t rectify
molecular weight…….35 immediately
g therefore thye
Sodium requested to
Chloride….….…..8.50 g postpone till next
Potassium DRB meeting.
Chloride….……0.7 g
Calcium
chloride…….....0.38 g
(Plasma Substitute)

10. M/s. Bloom Darcin-250mg Capsules 1x6’s As Per 16-5- Method of

Pharmaceuticals Each capsule contains:- SR 2013 Manufacturing
, Hattar Azithromycin dihydrate) Detail required for
≡ >45% humidity
Azithromycin……..….250 and >30 C
mg temperature.
(Macrolide) Method of
Analysis
Method (Limits) are
for Doxycycline
Hyclate.
Method 2
Is
spectrophotometer
method but in detail
is given
Chromatograph
Specification.
Clinical
Indication Vogue.
03 years shelf
life
Stability Studies
not given
Type of Mixer
(Bottle Mixer)

147
 not clear.
Not
recommended.
Shortcoming
rectified
11. M/s. Genome Ibufam Tablets 10’s As Per 2-5- Dual core tablet
Pharmaceutical Each film coated tablet SRO 2013 machine
s, Hattar contains:- unavailable. To
Ibuprofen………..800 be deferred.
mg Outline of
Famotidine……..26.6 mg method of
(NSAID/H2-receptor) manufacture
does not
contains the
coating process.
However, in
detailed
procedure it has
been given in
general.
IPA is
inflammable
substance.
Safety measures
for tray drawing
of materials
containing IPA
has not been
provided.
Specification of
sodium starch
glycolaed have
been provided in
dossier but the
material is not
reflecting in the
composition of
drug.
Recommended
with above
corrections.

148
12. M/s. Onyx Sulpride 50mg Tablets 1`0’s As Per 20-5- Minor
Pharmaceutical Each tablet contains:- SRO 2013 shortcoming
s, Mansehra Levosulpiride………..50 rectified.
mg
(Antidpressant/Anti-
gastroprokinetics)

Decsion: Registration Board decided as follows:

Products at S.No. 1, 2, 6, 7, 10 and 12 approved for registration, as firms have
rectified shortcomings in registration dossiers.
Products at S.No. 3, 4 and 5 deferred for discussion in forthcoming meeting in light
of contract manufacturing policy.
Products at S.No. 8 and 9 deferred for PSI by Director DTL, Peshawar and area
FID. For product at S.No.9, firm will rectify shortcomings as mentioned above.
Products at S.No.11 for correction of shortcomings.

149
Case No.12: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.
Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th
meeting as under:-

Name of the drugs with Pack Proposed Decision

composition Size Price
Epipro CR Tablets 5x10’s As per SRO Deferred for
submission of
Each tablet contains:- comparative
Divalproex Sodium dissolution profile
USP……..500mg with originator and
relative documents.
(Anti-Epileptics)

The firm has submitted comparative dissolution profile of their product EPIPRO CR Tablet with
originator reference product Tablet EPIVAL CR of M/s Abbott Laboratories Pakistan Ltd.
Decision: The Drug Registration Board deferred the case till expert evaluation of
comparative dissolution profile documents by Director DTL Peshawar.
Case No.13: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.

Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th
meeting for confirmation of formulation in developed countries.
Name of the drugs with Pack Proposed Decision
composition Size Price
CIP Suspension 10% 60ml As per SRO Deferred for
confirmation of
Each 5ml contains:- 100ml formulation in
Ciprofloxacin HCl developed countries.
USP……..500mg
(Anti-Biotic)

The firm has submitted that the drug is approved by US-FDA with the name of CIPRO for M/s
Bayer Pharmaceuticals Corporation, USA and provided copies of references (approvals / study).
The firm also submitted that the same formulation has been approved in 227th meeting of DRB
held on 26-27 Aug 2010 for M/s Wilshire Lab. Lahore and Drug Pricing Committee fixed its
price in its 14th meeting held on 11th January 2011. It is submitted that ciprofloxacin
microcapsules in base form is used in FDA approved Bayer’s Cipro formulation. Price has also

150
 been approved for base form as Microencapsulated Ciprofloxacin eq.to Ciprofloxacin ….500mg,
while in this formulation Ciprofloxacin HCl has been applied.
Decision: The Drug Registration Board deferred the case for confirmation of USFDA
approval of formulation and confirmation of formulation with originator.

Case No.14: Grant of registration-New formulation & fast track.

Following firms have applied following products on Form 5-D as new applications and fast track
fee. Decision is recorded in last column.

S.N Name of Name of the drugs with Pack Proposed Date of Decision
o Firm composition Size Price Submission

1. M/s Saffron Provate GM Topical Ointment 20gm Rs.300.00 10-7-2013 Deferred for
Pharmaceut Each gram contains:- 10gm Rs.150.00 Rs.60,000/- confirmation
icals (Pvt) Betamethasone…0.05% w/w 05-09-2013 of availability
of
Ltd, Gentamicin….0.1% w/w Rs. 90,000/-
formulation
Faisalabad. Miconazole….2% w/w Form 5-D in FDA,
(cortisteriod/antibiotic/antifungal) EMA,
Australia and
Japan.

2. -do- Provate GM Topical Cream 20gm Rs.300.00 10-7-2013 Deferred for

Each gram contains:- 10gm Rs.150.00 Rs.60,000/- confirmation
Betamethasone…0.05% w/w 05-09-2013 of availability
of
Gentamicin….0.1% w/w Rs. 90,000/-
formulation
Miconazole….2% w/w Form 5-D in FDA,
(cortisteriod/antibiotic/antifungal) EMA,
Australia and
Japan.
3. M/s Tagipmet XR 100/1000Tablet N.A N.A 10-04-13 Deferred for
Highnoon Each bilayered tablet contains:- Rs. 150,000/- confirmation
Lab. Ltd. Sitagliptin (as Form-5D of availability
Lahore phosphate)…100mg of
Metformin HCl (as sustained formulation
release)…1000mg in FDA,
(Anti-diabetic) EMA,
Australia and
Japan.

151
4. -do- Tagipmet XR 50/500Tablet N.A N.A 10-04-13 Deferred for
Each bilayered tablet contains:- Rs. 150,000/- confirmation
Sitagliptin (as phosphate)…50mg Form-5D of availability
Metformin HCl (as sustained of
release)…500mg formulation
(Anti-diabetic) in FDA,
EMA,
Australia and
Japan.

5. -do- Tagipmet XR 50/1000Tablet 10-04-13 Deferred for

Each bilayered tablet contains:- Rs. 150,000/- confirmation
Sitagliptin (as phosphate)…50mg Form-5D of availability
Metformin HCl (as sustained of
release)…1000mg formulation
(Anti-diabetic) in FDA,
EMA,
Australia and
Japan.
6. -do- Axesom 10 Sachet 22-04-13 Deferred for
Each Sachet contains:- Rs. 150,000/- confirmation
Esomeprazole (as Magnesium Form-5D of availability
trihydrate) …10mg as Gastro- of
resistant granules formulation
in FDA,
EMA,
Australia and
Japan.
7. -do- Ebernet 1% Cream 10gm Rs.320.00 21-06-2011 Deferred for
Each gram contains:- Rs. 8000/- confirmation
Eberconazole (as nitrate)….10mg 27-06-2011 of availability
of
(anti fungal) Rs. 7000/-
formulation
10-7-2013 in FDA,
135000/- EMA,
(Total: Rs. Australia and
150000/-) Japan.
Form-5D
8. M/s Servier Daflon 1g Tablet 20’s Rs. 30-04-13 Deferred for
Research Each tablet contains:- 32.50/table Fee Rs. confirmation
and Diosmin… 900mg t 150,000/- of availability
Pharmaceut Hesperidine …100mg Form-5D of
icals (pvt). (Vascular protector and formulation
Ltd. Venotonic) in FDA,
Lahore. EMA,
Australia and

152
 Japan.

9. -do- Natrilam 10mg Tablets 30’s Rs.72.52/T 20-6-2012 Deferred for

Each tablet contains:- ablet Rs.8000/- confirmation
Indapamide SR…..1.5mg 30-04-13 of availability
Amlodapine Besilate…..10mg Rs. 130,000/- of
(Antihypertensive diuretic + Total Fee Rs. formulation
Calcium antagonist) 150,000/- in FDA,
Form 5-D EMA,
Australia and
Japan.

10. -do- Natrilam 5 mg Tablets 30’s Rs.36.26/t 05-04-2011 Deferred for

Each tablet contains:- ablet Rs.8000/- confirmation
Indapamide SR…..1.5mg 30-04-13 of availability
Amlodapine Besilate…..5mg Rs. 130,000/- of
(Antihypertensive diuretic + Total Fee Rs. formulation
Calcium antagonist) 150,000/- in FDA,
Form 5-D EMA,
Australia and
Japan.

11. -do- Natrilam 2.5 mg Tablets 30’s Rs.26.26/t 05-04-2011 Deferred for
Each tablet contains:- ablet Rs.8000/- confirmation
Indapamide SR…..1.5mg 30-04-13 of availability
Amlodapine Besilate…..2.5mg Rs. 130,000/- of
(Antihypertensive diuretic + Total Fee Rs. formulation
Calcium antagonist) 150,000/- in FDA,
Form 5-D EMA,
Australia and
Japan.

12. M/s. CCL OAB Tablets 4mg 28’s As per 03.02.2011 Deferred for
Pharmaceut Each tablet contains: brand Fee 15000 confirmation
icals, Fesoterodine Fumarate …. 4mg leader 20.05.2013 of availability
Lahore (Muscarinic receptor antagonist) Fee.135,000 of
Form 5-D formulation
in FDA,
EMA,
Australia and
Japan.

153
13. -do- OAB Tablets 8mg 28’s As per 03.02.2011 Deferred for
Each ER tablet contains: brand Fee 15000 confirmation
Fesoterodine Fumarate …… 8mg leader 20.05.2013 of availability
(Muscarinic receptor antagonist) Fee.135000 of
Form 5-D formulation
in FDA,
EMA,
Australia and
Japan.

14. -do- Virata Tablets 90mg 20’s As per 12.01.2012 Deferred for
Each tablet contains: brand Fee 15000 confirmation
Ticagrelor ………. 90mg leader 20.05.2013 of availability
(Platelet inhibitor) Fee.135000 of
Form 5-D formulation
in FDA,
EMA,
Australia and
Japan.
15. -do- Lina-Met 2.5/500 Tablet 14’s As per 08.04.2013 Deferred for
Each tablet contains: brand Fee 50000 confirmation
Linagliptin....................2.5mg leader Fee.100000 of availability
Metformin HCI………500mg 20.05.2013 of
Form-5D formulation
in FDA,
EMA,
Australia and
Japan.
16. -do- Lina-Met 2.5/850 Tablet 14’s As per 08.04.2013 Deferred for
Each tablet contains: brand Fee 50000 confirmation
Linagliptin…....................2.5mg leader Fee.100000 of availability
Metformin HCI…………850mg 20.05.2013 of
Form-5D formulation
in FDA,
EMA,
Australia and
Japan.
17. -do- Lina-Met 2.5/1000 Tablet 14’s As per 08.04.2013 Deferred for
Each tablet contains: brand Fee 50000 confirmation
Linagliptin ......................2.5mg leader Fee.100000 of availability
Metformin HCI……….1000mg 20.05.2013 of
Form-5D formulation
in FDA,
EMA,
Australia and
Japan.

154
18. M/s Neutro Nupreced Injection 2ml Rs. 5500/- 17-05-13 Deferred for
, Lahore Each 2ml contains:- per Fee Rs. confirmation
Dexmedetomidine ampoule 60,000/-+ Rs. of availability
Hydrochloride…200mcg 90,000(28- of
(Sedative) 05-13) formulation
Form5-D in FDA,
EMA,
Australia and
Japan.

155
Case No.15. Extension in Contract Manufacturing Permissions:

Following cases were considered and decided by the Registration Board in 238th meeting but erroneously missed in minutes. The
decision of Board is recroded in last column.

156
S.# Name of Name of Reg. Name of Drug with Date & diary # Category Decision
Applicant Manufacturer No. composition & Fee
1. M/s Noble M/s EG 023134 Cefodime Injection 15-04-13 import to local Extended till
Pharmaceutical, Pharmaceutical Each vial contain: Dy. contract 30.06.2015
Islamabad Islamabad earlier Ceftazidime……..1gm No.2248R&I manufacturing
approved Dy. No. 1356.
manufacturer DDC(R-III)
was Biorex Rs.50000/
Pharmaceutical Rs.8000/-(23-
Islamabad 06-2010)
2. -do- -do- 023135 Cefodime Injection -do- -do- -do-
Each vial contain:
Ceftazidime…..250gm
3. M/s Focus & M/s Bio Labs. 054652 Ruzone Injection 250mg 15-04-13 Dedicated Extended till
Rulz (Pvt) Ltd, Each Vial Contains:- Dy. facility 30.06.2015. The
Pharmaceutical, Islamabad earlier Ceftriaxone Sodium No.1251R&I Cephalosporin firm will deposit
Islamabad approved equivalent to Rs.20,000/ remaining fee &
manufacturer Ceftriaxon…250mg select IM/IV
was M/s Spadix (USP Specification)
Pharmaceutical,
Islamabad

4. -do- -do- 054653 Ruzone Injection 500mg -do- -do- -do-

` Each Vial Contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…500mg
(USP Specification)
5. -DO- -do- 054654 Ruzone Injection 500mg -do -do- -do-
Each Vial Contains:-
Ceftriaxone Sodium
equivalent to

157
 Ceftriaxone…500mg
(USP Specification)

6. -do- -do- 054655 Trag Injection 250mg -do- -do- Extended till
Each Vial contains:- 30.06.2015. The
Cefotaxime sodium firm will deposit
equivalent to remaining fee
Ceftotaxime…250mg
7. -do- -do- 054656 Trag Injection 500mg -do- -do- -do-
Each Vial contains:-
Cefotaxime sodium
equivalent to
Ceftotaxime…500mg
8. -do- -do- 054657 Trag Injection 500mg -do- -do- -do-
Each Vial contains:-
Cefotaxime sodium
equivalent to
Ceftotaxime…500mg
9. M/s Medley M/s Fassgen 030245 Qsef Injection 250mg 15-04-13 Dedicated Extended till
Pharmaceutical, Pharmaceutical Each vial contain:- Dy. No.2319 facility 30.06.2015
Plot 41-A, P.S.I. Hatter. Earlier Cefotaxime Sodium eq. R&I Cephalosporin
E. Jhang Bahtar approved to Cefotxime Dy. No.
Road Wah Cantt. contract …….250mg 1358D.D.C(R-
Rawalpindi manufacturer III)
was M/s Neutro Rs.50000/-
Pharma Hattar
10. -do- -do- 030246 Qsef Injection 500mg -do- -do- -do-
Each vial contain:-
Cefotaxime Sodium eq.
to Cefotxime
…….500mg
11. -do- -do- 030247 Qsef Injection 1gm -do -do- -do-

158
 Each vial contain:-
Cefotaxime Sodium eq.
to Cefotxime
…….1gmmg
12. -do- -do- 030243 Kintrex 500mg Injection -do- -do- Extended till
I.V 30.06.2015. the firm
Each vial contains:- will select either
Ceftriaxone Sodium eq. IM/IV
to. Cefriaxone….500mg
13. -do- -do- 030244 Kintrex 1gm Injection -do- -do- -do-
I.V
Each vial contains:-
Ceftriaxone Sodium eq.
to. Cefriaxone….1gm
14. -do- -do- 030241 Kintrex 500mg Injection -do- -do- -do-
I.M
Each vial contains:-
Ceftriaxone Sodium eq.
to. Cefriaxone….500mg
15. M/s Goodman M/s Spadix 056677 Martazone 250mg IM 11-02-13 Dedicated Extended till
Laboratories, Pharmaceutical Injection Dy. No.1497 facility 30.06.2015. the firm
Islamabad Islamabad. Each vial contains:- R&I Cephalosporin will deposit
Earlier approved Ceftriaxone Sodium Dy. No. remaining fee &
contract equivalent to 41D.D.C(R- slect IM/IV
manufacturer Ceftriaxone…250mg III)
was M/s Global (USP Specification) Rs.20000/-
Pharmaceutical Extended till
Islamabad 30.06.2015
& Rs.8000/-
(29-09-2010)

16. 056678 Martazone 500mg IV -do- -do- -do-

Injection

159
 Each vial contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…500mg
(USP Specification)
17. 056679 Martazone 1gm IV -do- -do- -do-
Injection
Each vial contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…1gm
(USP Specification)
18. M/s Fassgen M/s Medley 056452 Stigen 0.5mg Injection Fee not General Deferred since the
Pharmaceutical, Pharmaceutical, Each ml contains:- deposited products request of firm does
Hattar Wah Cantt. Neostigmine Dy. No. 1378 not fall under
Earlier approved Methylsuphate….0.5mg Dated:09-05- present contract
contract (USP specification) 2013 policy & applicant
manufacturer has to deposit fee.
was M/s
WelMark
Pharmaceuticals
Hattar
19. -do- -do- 056453 Traxic 250mg Injection -do- -do- -do-
Each 5ml contains:-
Tranexamic
Acid…..250mg
(B.P Specification)
20. -do- -do- 056454 Traxic 500mg Injection -do- -do- -do-
Each 5ml contains:-
Tranexamic
Acid…..500mg
(B.P Specification)
21. -do- -do- 056456 Dyronex 500 Infusion -do- -do- -do-

160
 Each 100ml contains:-
Metronidazole USP
(USP Specification)
22. -do- -do- 056457 Cebect Infusion 200mg -do- -do- -do-
Each 100ml contains:-
Ciprofloxacin Lactate
eq. to Ciprofloxcin
USP…..200mg
(USP Specification)
23. -do- -do- 056458 Vectra 75mg Injection -do- -do- -do-
Each 3ml contains:-
Diclofenac Sodium
…….75mg
(Medley Specification)
24. -do- -do- 056459 Pepgen 20mg Injection -do- -do- -do-
Each 2ml contains:-
Famotidine………20mg
(Medley Specification)
25. -do- -do- 056461 Suxagen 100mg -do- -do- -do-
Injection
Each 2ml contains:-
Suxamethonium
Chloride BP…..100mg
(Medley Specification)
26. -do- -do- 056462 Artegen 80mg Injection -do- -do- -do-
Each 1ml coantains:-
Arthemether………..80
mg
(Medley Specification)
27. -do- -do- 056463 Vibra 40mg Injecgion -do- -do- -do-
Each 1ml contain:-
Triamcinolone
acetonide

161
 BP………40mg
(B.P Specification)
28. -do- -do- 056464 Mecobon 500mg -do- -do- -do-
Injection
Each 1ml Contain:-
Mecobalamine
………500mcg
(Medley Specification)
29. -do- -do- 056466 Fasdic Injection -do- -do- -do-
Each 2ml ampoule
contains:-
Diclofenac sodium
75mg
Lidocain HCl…..20mg
(Medley Specification
30. -do- -do- 056825 Levotar Infusion 500mg -do- -do- -do-
Each vial contain:-
Levofloxacin (as
hemihydrates)…..500m
g
(Medley specification)
31. -do- -do- 056826 Fasicam 20mg Injection -do- -do- -do-
Each 1ml apoule
contains:
Piroxicam USP….20mg
(Medley Specification)
32. M/s Danas M/s Global 045077 Burgundy Igm Injection 15-04-13 Dedicated Extended till
Pharmaceutical, Pharmaceutical, Each Vial contain: Dy. No.2218 facility 30.06.2015. The
Islamabad Islamabad. Ceftriaxone R&I Cephalosporin firm will select
Earlier approved (as Sodium)…...1gm Dy. No. IM/IV
contract (USP Specification) 115D.D.C
manufacturer (R-III)
was M/s Florence Rs.42000/-

162
 Islamabad Rs.8000/-(30-
09-2010)
33. -do- -do 045078 Burgundy 250mg -do- -do- -do-
Injection
Each Vial contain:
Ceftriaxone (as Sodium)
……..250mg
(USP Specification)
34. -do- -do- 045079 Burgundy 500mg -do- -do- -do-
Injection
Each Vial contain:
Ceftriaxone (as Sodium)
……..500mg
(USP Specification)
35. -do- -do- 045080 Milkish 1gm Injection -do- -do- Extended till
Each Vial contain: 30.06.2015
Cefepime (as HCl with
L-Arginine)
……..1gm
(USP Specification)
36. -do- -do- 045081 Milkish 500mg -do- -do- -do-
Injection
Each Vial contain:
Cefepime ( as HCl with
L-Arginine)
……..500mg
(USP Specification)
37. -do- -do- 045093 Joop 1gm Injection -do- -do- -do-
Each Vial contains:
Cefoperazone (as
Sodium)……….0.5gm
Sulbactam (as
Sodium)………0.5gm

163
 (USP Specification)
38. -do- -do- 045094 Joop 2gm Injection -do- -do- -do-
Each Vial contains:
Cefoperazone (as
Sodium)…….1gm
Sulbactam (as
Sodium)……1gm
(USP Specification)
39. M/s Benson M/s Shawan 060423 Triben 1gm Injection Dy. No. 2274 Dedicated Extended till
Pharmaceuticals Pharmaceuticals, I/V R&I 15-04-13 facility 30.06.2015. The
Islamabad. Each vial contains:- Dy. No.1168 Cephalosporin firm will select
Earlier approved Ceftriaxone Sodium eq. DDC(R-III) either IM/ IV
contract to Ceftriaxone …..1gm (22-2-2013)
manufacturer (USP Specs.) Rs.20,000/-
was (22-4-2013)&
M/s Fassgen Rs. 30,000
Pharmaceuticals, (15-4-2013)
Lahore
40. 060424 Triben 500mg Injection Dy. No. 2275 -do- -do-
I/V R&I 15-04-13
Each vial contains:- Dy. No.1176
Ceftriaxone Sodium eq. DDC(R-III)
to (22-2-2013)
Ceftriaxone………..500 Rs.20,000/-
mg (22-4-2013)&
(USP Specs.) Rs. 30,000
(15-4-2013)

41. 060425 Triben 250mg Injection Dy. No. 2283 -do- -do-
I/V R&I 15-04-13
Each vial contains:- Dy. No.1167
Ceftriaxone Sodium eq. DDC(R-III)
to Ceftriaxone...250mg (22-2-2013)

164
 (USP Specs.) Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)

45. 060426 Benzone 1gm Injection Dy. No. 559 -do- Extended till
Each vial contains:- R&I 22-02-13 30.06.2015.
Cefoperazone (as Dy. No.1169
Sodium)……..500mg DDC(R-III)
Sulbactam (as (22-2-2013)
Sodium)…………500m
g Rs.20,000/-
(USP Specs.) (22-4-2013)&
Rs. 30,000
(15-4-2013)
46. 060427 Benzone 2gm Injection Dy. No. 2280 -do- -do-
Each vial contains:- R&I 15-04-13
Cefoperazone (as Dy. No.1170
Sodium)……..1gm DDC(R-III)
Sulbactam (as (22-2-2013)
Sodium)…………1gm Rs.20,000/-
(USP Specs.) (22-4-2013)&
Rs. 30,000
(15-4-2013)

47. 060428 Benpime 1gm Injection Dy. No. 2281 -do- -do-
Each vial contains:- R&I 15-04-13
Cefepime (as HCl) Dy. No.1171
…….1gm DDC(R-III)
(USP Specs.) (22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000

165
 (15-4-2013)

48. 060429 Benpime 500mg Dy. No. 2276 -do- -do-

Injection R&I 15-04-13
Each vial contains:- Dy. No.1174
Cefepime (as HCl) DDC(R-III)
…….500mg (22-2-2013)
(USP Specs.) Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)

49 053607 Taxiben 250mg Dy. No. 2282 -do- -do-

Injection R&I 15-04-13
Each vial contains:- Dy. No.1173
Cefotaxime (as DDC(R-III)
Sodium)………250mg (22-2-2013)
(USP Specs.) Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)

50. 053608 Taxiben 500mg Dy. No. 2277 -do- -do-

Injection R&I 15-04-13
Each vial contains:- Dy. No.1172
Cefotaxime (as DDC(R-III)
Sodium)………500mg (22-2-2013)
(USP Specs.) Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)

51. 053609 Taxiben 1gm Injection Dy. No. 2278 -do- -do-

166
 Each vial contains:- R&I 15-04-13
Cefotaxime (as Dy. No.1175
Sodium)………1gm DDC(R-III)
(USP Specs.) (22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)

52. M/s Drugs Inn M/s EG 022619 Prezone 250mg IM/IV 12-04-13 import to local Extended till
Pharmaceutical Pharmaceutical, Injection Dr. contract 30.06.2015. The
Islamabad Islamabad. Each vial contains:- No.1060R&I manufacturing firm will select
Earlier approved Ceftriaxone Sodium eq. Dy. No. either IM/ IV
contract to 250mg Ceftriaxone 1212D.D.C(R-
manufacturer Sodium base. III)
was M/s Biorex Rs.42000/-
Pharmaceutical Rs.8000/-
Islamabad (23-06-2010)
53. -do- -do- 023168 Prezone 500mg -do- -do- -do-
Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 500mg
Ceftriaxone Sodium
base.
54. -do- -do- 022654 Prezone 1GM Injection -do- -do- -do-
Each vial contains:-
Ceftriaxone Sodium eq.
to 1gm Ceftriaxone
Sodium base.
55. -do- -do- 022694 Kefcef 250mg Injection -do- -do- -do-
Each vial contains:-
Ceftriaxone Sodium eq.

167
 to 250mg Ceftriaxone
Sodium base.
56. -do- -do- 022695 Kefcef 500mg Injection -do- -do- -do-
Each vial contains:-
Ceftriaxone Sodium eq.
to 500mg Ceftriaxone
Sodium base.
57. -do- -do- 022696 Kefcef 1gm Injection -do- -do- -do-
Each vial contains:-
Ceftriaxone Sodium eq.
to 1gm Ceftriaxone
Sodium base.
58. -do- -do- 022653 Gencef 1gm Injection -do- -do- Extended till
Each Vial contains:- 30.06.2015.
Ceftotaxim Sodium eq.
to 1gm Cefotaxime
Sodium base.
59. M/s Well Care M/s Fassgen 060808 Carewel 250mg 15-04-13 Dedicated Extended till
Pharmaceutical, Pharmaceutical Injection Dr. No.2314 facility 30.06.2015. The
A/7 P.S.I.E Hatter.Earlier Each injection contains: R&I Cephalosporin firm will select
Sargodha approved Ceftriaxone sodium eq Dy. No. either IM/ IV
contract to Ceftriaxone 1363D.D.C(R-
manufacturer U.S.P……50mg. III) .
was M/s Neutro Rs.50,000/-
Pharmaceutical
Lahore.
60. -do -do- 060809 Carewel 500mg 15-04-13 -do- -do-
Injection Dr. No.2314
Each injection contains: R&I
Ceftriaxone sodium eq Dy. No.
to Ceftriaxone U.S.P… 1356D.D.C(R-
500mg III)
Rs.50,000/-

168
61. -do -do- 060810 Carewel 1gm Injection -do- -do- -do-
Each injection contains:
Ceftriaxone sodium eq
to Ceftriaxone
U.S.P…….1gm

62. M/s Salus M/s Warafana 021057 Salxone 0.25gm 19-12-11 import to local Extended till
Pharmaceutical Pharmaceutical Injection Dy. No.993 contract 30.06.2015. The
Rawalpindi Islamabad Each Vial Contains: R&I manufacturing firm will select
Ceftriaxone Sodium Dy. No. either IM/ IV.
Eq. to Ceftriaxone 1415D.D.C(R-
….0.25gm III) .
Rs.50,000
63. -do- 021058 Salxone 1gm Injection 19-12-11 -do- -do-
Each Vial Contains: Dy. No.993
Ceftriaxone Sodium R&I
Eq. to Ceftriaxone Dy. No.
….1gm 1416D.D.C(R-
III)
Rs.50000
64. -do- 021059 Salxone 0.5gm Injection 19-12-11 -do- -do-
Each Vial Contains: Dy. No.993
Ceftriaxone Sodium R&I
Eq. to Ceftriaxone Dy. No.
….0.5gm 1417D.D.C(R-
III)
Rs.50000

169
 Case No.16. Correction in minutes of 238th meeting.

a. Grant of registration-Vetrenary Drugs:

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision Correct

Applicant Size Life recoded in Decision
238th
meeting

1. M/s. Noble Nobiaminox Injection Decontrolled 02 Deferred for Approved

Pharma, Mir Pur 100ml years application However the
Each ml contains:-
Azad Kashmir. 200ml on Form 5 D Registration
Novaminsulfon……..40.00mg 450ml along with Board
Etilefrin……………...0.20mg 500ml revised Fee. advised the
1000ml registration
Calcium Gluconate……..100.00mg sections to
Magnesium Gluconate…..10.00mg again review
the
Nicotinamide……..….0.03mg Registration
Caffeine………….…10.00mg Dossiers
before
Sodium Salicylate………...7.00mg issuance of
Boric Acid………….10.00mg Registration
letters.
(Electrolytes)

2. M/s. A & K Adeka Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 50ml years
Each 1ml contains:-
Sargodha Road, 100ml
Faisalabad. Vitamin A………..100000 IU
Vitamin D3………40000 IU
Vitamin E………..40mg
(Nutritional Supplement).

3. M/s. A & K Genin Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Tylosin Tartrate………..100mg 50ml
Gentamycin Sulphate….50mg 100ml

(Antibiotic).
4. M/s. A & K Genak-10 Injection Decontrolled 02 -Do- -Do-
Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Gentamycin Sulphate…100mg 50ml
100ml

170
 (Antibiotic).
5. M/s. A & K Ectin Injection Decontrolled 02 -Do- -Do-
Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Ivermectin…………10mg 50ml
(Anthelemtic). 100ml

6. M/s. A & K Fenak Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Ketoprofen…………100mg 50ml
(NSAID). 100ml

7. M/s. A & K Folak Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Florfenicol…………300mg 50ml
(Antibiotic). 100ml

8. M/s. A & K Tine-20 Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Tylosin Tartrate……..200mg 50ml
(Antibiotic). 100ml

9. M/s. A & K Rofox-10 Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Enrofloxacin……….100mg 50ml
(Antibiotic). 100ml

10. M/s. A & K FMO Injection Decontrolled 02 -Do- -Do-

Pharmaceutical, 10ml years
Each 1ml contains:-
Sargodha Road, 20ml
Faisalabad. Oxytetracycline BP………..300mg 50ml
Flunixine Meglomine USP..20mg 100ml

(Antibiotic).

171
 b. Grant of registration-Human drugs:
S. # Name of Name of Drug(s)/Composition Price/Pack MRP Decision Correct
Applicant Size recoded in Decision
238th
meeting
1 M/s. Saaaf Heap Syrup 120ml As Per Deferred for Approved
Pharmaceuticals, Each 5ml contains:- SRO fee The
Risalpur. Iron (III) polymaltose complex eq. to Registration
elemental iron ………50mg Board
Folic Acid……………0.35mg
advised the
(Heamatinic)
Registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
Domprid Suspension 60ml As Per -Do- -Do-
Each 5ml contans:- 120ml SRO
Domperidone……….5mg
(Antidopaminergic)

Zinc Saf Suspension 60ml As Per -Do- -Do-

Each 5ml contains:- 120ml SRO
Zinc Sulphate ……….20mg
(Antidiarroeals)

Diasaf Plus Suspension 60ml As Per -Do- Deferred for

Each 5ml contains:- 120ml SRO review of
Metronidazole……………75mg formulation by
Furazolidone……………..25mg review
(Amobecide) committee

Losaf Suspension 60ml As Per -Do- Approved

Each 5ml contains:- 120ml SRO The
Loratadine…………5mg Registration
(Antihistamine) Board
advised the
Registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters

172
 c. Registration Board in 238th meeting extended following contract manufacturing permissions for Khos Pharma, Hyderabad. But
scrutiny of record revealed that these products are registered for M/s Treat Pharma, Bannu. Correct details are as follows:

M/s Treat M/s Mediate 073248 K-Xime Suspension 15-04-2013 Dedicated Extended till 30.06.2015.
Pharma, Bannu Pharmaceuticals, Each 5ml contains: DyNo.229 facility
Karachi Cefixime……….200 mg Form-05 Cephalosporin
Rs.42,000/-
Rs.8000/-
18.08.2011

-do- -do- 073247 K-Xime Suspension 15-04-2013 Dedicated Extended till 30.06.2015.
Each 5ml contains: DyNo.229 facility
Cefixime……….100 mg Form-05 Cephalosporin
Rs.42,000/-
Rs.8000/-
18.08.2011

-do- -do- 073246 K-Xime Capsule 15-04-2013 Dedicated Extended till 30.06.2015.
Each capsule contains: DyNo.229 facility
Cefixime……….400 mg Form-05 Cephalosporin
Rs.42,000/-
Rs.8000/-
18.08.2011

d. Registration Board in 238th meeting extended following contract manufacturing permissions for contract manufactured by M/s
AGP Health Care Pvt. (Formerly, Eli Lilly Gohar, Karachi). Later on scrutiny of record revealed that contract manufacturer is M/s
PharmEvo, Karachi. Submitted for correction and issuance of corrigendum as per following correct details.

M/s AGP, Kar. M/s PharmEvo, 003755 Kefzol 500mg Injection 12-04-2013 Dedicated Extended till 30.06.2015
Karachi Each vial contains: DyNo.308 facility

173
 Cefazolin sodium……….…500mg Form-05 Cephalosporin
Rs.42,000/-
Rs.8000/-
02-6-2011
-do- -do- 003756 Kefzol 1g Injection 29-04-2013 -Do- Extended till 30.06.2015
Each vial contains: DyNo.309
Cefazolin sodium……….…1gm Form-05
Rs.42,000/-
Rs.8000/-
02-6-2011

Case No.17. Extension in contract manufacturing permissions.

M/s Sapient M/s Mediate 060472 COA Dry Suspension 15-04-2013 Dedicated Extended till 30.06.2015.
Pharma, Lhr Pharmaceuticals, Each 5ml contains: Form-05 facility
Kar. Cefixime……….200 mg Rs.42,000/- Cephalosporin
Rs.8000/-
07.09.2010

-do- -do- 060473 COA Capsule 15-04-2013 Dedicated Extended till 30.06.2015.
Each capsule contains: Form-05 facility
Cefixime……….400 mg Rs.42,000/- Cephalosporin
Rs.8000/-
07.09.2010

174
 (Medical Devices)

Case No.18. Applications for registration of Medical Devices for Import.

The Registration Board considered the following applications of medical

devices and decided as mentioned against each. These applicationshave already been
recommended by Expert Committee on Medical Devices. Approved applications are subject to
inspection of manufacturer abroad, verification of storage facilities etc as per policy.

A: CATHETERS:

S.No. Name of Importer and Name of Medical Demanded Shelf life Decision
Manufacturer/Exporter. Device. price &
Pack size
1. M/s.Cor-Med, Fairway Decontrolled 24 Approved.
2nd Floor, 36/62, Rehman Rapid Exchange months
Plaza, Bank Road, Saddar, dilatation catheter for (Different
Rawalpindi PTCA product codes
Manufactured by Length (mm): available)
M/s. IHT, Iberhospitex 10,15,20, 25,30, 35,40.
S.A, Barcelona, Spain
Dia (mm):
1.5, 2.0, 2.5, 3.0, 3.5,
4.0, 4.5.

B: STENTS:

S.No. Name of Importer and Name of Medical Demanded Shelf life Decision
Manufacturer/Exporter. Device price &
Pack size
1. M/s.Cor-Med, Bionert Inert Coronary Decontrolled 24 Approved.
2nd Floor, 36/62, Rehman Stent months
Plaza, Bank Road, Saddar, (Bare Metal Stent) (Different
Rawalpindi product
Bionert : codes
Manufactured by
Stent Length (mm):
M/s. IHT, Iberhospitex S.A, available)
9, 14, 18, 23, 28, 36.
Barcelona, Spain.
Stent Dia (mm):
3.0, 3.50, 4.00, 4.50.
Bionert Small:
Stent Length (mm):
9, 14, 19, 23, 28.

175
 Stent Dia (mm):
2.0. 2.25, 2.50, 2.75.

2. M/s.Cor-Med, Active Paclitaxel Decontrolled 18 Approved.

2nd Floor, 36/62, Rehman Eluting Coronary months
Plaza, Bank Road, Saddar, Stent.
Rawalpindi Active : (Different
Manufactured by Stent Length (mm): product
M/s. IHT, Iberhospitex S.A, 9, 14, 18, 23, 28, 36. codes
Barcelona, Spain. available)
Stent Dia (mm):
3.0, 3.50, 4.00, 4.50.
Active Small:
Stent Length (mm):
9, 14, 19, 23, 28, 36.
Stent Dia (mm):
2.0. 2.25, 2.50, 2.75.

C: SYRINGES:

S.No. Name of Importer and Name of Medical Device. Demanded Shelf Decision
Manufacturer/Exporter. price & life
Pack size
1. M/s. Excel Corporation, A-Star Disposable syringe Decontrolled 5years Approved.
435 BYJ Society, 1ml
Bahadurabad, Karachi 3ml
Manufactured by 5ml
M/s. Changzhou Jinliyuan 10ml
Medical Devices, Co., Ltd., 20ml
No.6 West Xihe Road,
Sanhekou, Zhenglu Town,
Wujin District, Changzhou
City, China.

2. M/s. Excel Corporation, A-Star Disposable syringe Decontrolled 5years Approved.

435 BYJ Society, 30ml
Bahadurabad,Karachi 50ml
Manufactured by
M/s. Changzhou Jinliyuan
Medical Devices, Co., Ltd.,
No.6 West Xihe Road,
Sanhekou, Zhenglu Town,
Wujin District, Changzhou
City, China.

3. M/s Becton Dickinson BD Emerald TM Pro (Reuse Decontrolled 5 years Approved.

Pakistan (Pvt) Ltd, Prevention) Luer Slip

176
 19-D/1, Gulberg-III, Syringe. 2ml
Lahore. 5ml
10ml
Manufactured by:
M/s Becton Dickinson, S.A.
Ctra. Mequinenza, s/n
22520 Fraga (Huesca),
Spain.

Case No.19. Registration of Medical Devices of M/s Otsuka Pakistan Limited, Lasbela
Distt. Balochistan.

Registration Board in its 230th meeting considered and approved the following
medical devices of M/s. Otsuka Pakistan Limited, Lasbela Distt. Balochistan subject to
inspection of manufacturer abroad, local storage facility etc:-

S.No. Name of Importer and Name of Drug (s) Demanded Shelf Life
Manufacturer / Exporter. Composition & Price &
Therapeutic Group. Pack Size.
1. M/s. Otsuka Pakistan Limited, Jive PTCA Balloon Decontrolled 02 years
Lasbela Distt. Balochistan. / Catheter
(Medical Device).
M/s. Mircroport Medical
(Shanghai) Co. Ltd.,
Shanghai. P.R. China.
2. M/s. Otsuka Pakistan Limited, Mustang Stent Decontrolled 02 years
Lasbela Distt. Balochistan. / Stainless Steel
Coronary Stent
M/s. Mircroport Medical System
(Shanghai) Co. Ltd., (Medical Device).
Shanghai. P.R. China.

3. M/s. Otsuka Pakistan Limited, Firebird Rapamycin Decontrolled 12 months

Lasbela Distt. Balochistan. / Eluting Stainless
Steel Coronary Stent
M/s. Mircroport Medical System
(Shanghai) Co. Ltd., (Medical Device).
Shanghai. P.R. China.
4. M/s. Otsuka Pakistan Limited, Firebird 2 Decontrolled 09 months
Lasbela Distt. Balochistan. / Rapamycin Eluting
Cobalt Chromium
M/s. Mircroport Medical Coronary Stent
(Shanghai) Co. Ltd., System
Shanghai. P.R. China. (Medical Device).

177
 Accordingly inspection of M/s. Microport Medical (Shanghai) Co. Ltd., Shanghai.
P.R. China was conducted by the nominated panel. During the inspection, the panel of
inspectors observed certain shortcomings related to GMP and therefore did not recommend the
products for registration.

M/s Microport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China submitted an
Action Plan for taking corrective actions on the deficiencies mentioned in the inspection report.
After that M/s Otsuka Pakistan Ltd., Karachi submitted the Corrective Action Report dated 12th
October, 2012, forwarded by their principal manufacturer in which the manufacturer submitted
that they have taken Corrective Action on the non-conformities mentioned in the inspection
report and are ready for re-inspection of their premises.
Accordingly a panel of inspectors was nominated for re-inspection. The panel
conducted the inspection of all key manufacturing areas which were involved in manufacturing
and quality control of applied products. The points observed by the previous panel were also
checked. The panel has given the following recommendations:-
(i) Mustang Stent Stainless Steel Coronary Stent System is recommended for
grant of registration with shelf life of 24 months alongwith following sizes:-
Stent Dia (mm): 2.0, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00,
4.50, 5.00.
Stent Length (mm): 5 to 40.

(ii) Firebird 2 Rapamycin Eluting Cobalt Chromium Coronary Stent System is

recommended for grant of registration with shelf life of 12 months alongwith
following sizes:-
Stent Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0.
Stent Length (mm): 13, 18, 23, 29, 33.
Quantity of Rapamycin
Coated on stent (µg): 120, 160, 210, 268, 305.

(iii) Jive PTCA Balloon Dilatation Catheter is not recommended for grant of
registration because the product is neither registered by SFDA China nor
available in China. However, the firm manufactures it for export purpose only.

(iv) Firebird Rapamycin Eluting Stainless Steel Coronary Stent System is not
recommended for grant of registration because the registration status of the
product by SFDA China is valid till April, 2013 and firm has already

178
 discontinued its domestic sale hence it’s not on free sale in China. Moreover,
management of M/s Microport also informed that they don’t intend to apply for
extension of its registration beyond April, 2013 for local sale. However, they
will continue to export the product, if ordered.

Decision: The Board approved Mustang Stent Stainless Steel Coronary Stent System with
shelf life 24 months and Firebird 2 Rapamycin Eluting Cobalt Chromium
Coronary Stent System with increased shelf life of 12 months as recommended by
the panel of inspectors while the Board rejected Jive PTCA Balloon Dilatation
Catheter and Firebird Rapamycin Eluting Stainless Steel Coronary Stent
System as recommended by the panel of inspectors.

179
 Biological Evaluation & Registration

Case No.20: Import in GE pack and Local Printing of Reg. No., MRP and Urdu
labelling at own licensed site: F-268, SITE, Karachi having DML No. 000233

M/s GlaxoSmithKline, Karachi has requested import of Fluarix in GE packing and local
printing of Registration number, MRP, and Urdu version at their licensed site at F-268, SITE,
Karachi DML No. 000233.
The reason is because of centralized manufacturing at one Global manufacturing site at
GlaxoSmithKline, Belgium where the GE packs are now manufactured and due to production
time constraints the seasonal flu vaccine has one year shelf life and 6 month window period in
which it is to be used. Pakistan specific packing is not possible in this short time hence
availability in Pakistan is a major issue. Therefore Reg. No., MRP and Urdu instructions can
be printed at the company’s own licensed site at Karachi for a period of two years.
Fee Rs 5000/- has been paid by the firm.
Board is requested to allow the permission for import of Fluarix vaccine in GE packing and
local printing of Reg. No., MRP., and Urdu printing with inject printing at GlaxoSmithKline,
Karachi licensed site F-268, SITE, Karachi having DML No. 000233.
Decision: Board permitted the import of Fluarix vaccine in GE packing and local
printing of Reg. No., MRP., and Urdu version with inject printing at GlaxoSmithKline,
F-268, SITE, Karachi having DML No. 000233 for a period of two years.

Case No.21: Registration letter correction- Fluarix vaccine reg no. 022612.

M/s GlaxoSmithKline, Karachi’s Fluarix vaccine is an inactivated influenza vaccine (split

virion) containing antigens of at least three strains of the seasonal influenza viruses that are
notified by WHO for each year. Thus 15 mcg of haemagglutinin of each of the recommended
strain has to be added in the vaccine; therefore the wording on the Reg. letter needs to be
corrected to reflect the same as following:
Exiting wording on the Reg letter Correct wording as per CPP and Form 5
original application
“Each 0.5 ml vaccine dose contains: 15 mcg “Each 0.5 ml vaccine dose contains: 15 mcg
of haemagglutinin (inactivated and purified of haemagglutinin of each of the
split influenza vaccine)” recommended strain”.
The case was submitted on 19.09.2012.

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The Board is requested to please allow the correction to meet international requirements
subject to submission of fee by the firm.

Decision: The Board allowed the correction to meet international requirements subject
to submission of fee by the firm.

Case No. 22: Engerix B vaccines in prefilled syringes: 10 mcg Reg No. 012370; 20 mcg
Reg No. 009823
M/s GlaxoSmithKline, Karachi has requested import in GE packing and local printing of
Registration number, MRP, and Urdu version on their registered product at their licensed site
Karachi F-268, SITE, Karachi DML No. 000233. The reason is because of centralized
manufacturing at one Global manufacturing site at GSK Belgium where the GE packs are
now manufactured and due to production constraints Pakistan specific packing is not possible
hence availability is a major issue. Whereas the GE pack is readily available and can be
imported at the time of need and locally the Reg. No. MRP and Urdu instructions can be
printed at the company’s own site.
Fee Rs 5,000/- has been paid by the firm.
Board is requested to allow the permission for import of Engerix B vaccines in prefilled
syringes and in GE packing and local printing of Reg. No., MRP., and Urdu printing with
inject printing at GlaxoSmithKline, Karachi licensed site F-268, SITE, Karachi having DML
No. 000233.
Decision: Board allowed the permission to import Engerix B vaccines in prefilled
syringes in GE packing and local printing of Reg. No., MRP., and Urdu version with
inject printing at GlaxoSmithKline, F-268, SITE, Karachi having DML No. 000233 for a
period of two years.
Case No. 23: Registration of “Sterile water for injection-0.5ml vial” for reconstitution of
Vaxapox vaccine Reg No. 074628.

M/s Sind Medical Store, Karachi has requested that their varicella vaccine Vaxapox is
already registered vide reg no. 074628 to be imported from M/s Changchun BCHT
Biotechnology Co., Changchun China but the case of registration of its diluent was not
submitted at that time, hence the company is not able to market it in combo pack.
Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost.
Complete application on Form 5-A, product dossier, Embassy certified Free sale certificate,

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 CPP, copies of the cGMP certificate, and DML, are in file; the production and quality control
procedures are in order.
The Board is requested to grant registration of “Sterile water for injection-0.5ml” for
reconstitution of Vaxapox (Varicella) vaccine Reg No. 074628 to be supplied free of cost along
with the vaccine manufactured by the same company i.e., M/s Changchun BCHT Biotechnology
Co., Ltd., China.
Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.
Case No. 24: Registration of “Sodium Chloride Injection BP-0.1 ml ampoule for
reconstitution of BCG vaccine reg no. 053816.

M/s Hospital Services and Sales, Karachi has requested that their product BCG vaccine is
already registered but the case of registration of diluent to be supplied with the BCG vaccine for
its reconstitution was not submitted at that time to be imported together with the vaccine from
M/s Serum Institute of India Ltd., India in combo pack.
Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost. Complete
application on Form 5-A, product dossier, Embassy certified Free sale certificate, CPP, copies of
the cGMP certificate, and DML, are in file; the production and quality control procedures are in
order.
The Board is requested to grant registration of diluent to be supplied free of cost with the BCG
vaccine to be imported with vaccine from the same supplier in combo pack.
Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.
Case No. 25: Registration of “Diluent for Indirab injection-1.0 ml for reconstitution of
Indirab 1ml injection.

M/s Sind Medical Store, Karachi has requested their rabies vaccine Indirab injection which
was approved in the 227th meeting of DRB held on 26-27th, 2010 requires a diluent for the
reconstitution. The vaccine cannot be imported without the diluent which is to be supplied
free of cost. The vaccine registration letter has not been issued due to pending inspection.
Hence both the cases may be treated together for registration. Both the products are
manufactured by M/s Bharat Biotech International Limited, Andhra Pradesh, India. Fee Rs

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 50,000 thousand has been paid by the firm. The Board is requested to allow combining the
vaccine and its diluent case together for registration.

Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.

Case No. 26: Approved cases whose foreign inspections have been successfully
conducted:
a) M/s Hitech Pharmaceuticals, Lahore had applied for new site inspection of their three already
registered products with change of brand names and one diluent for vaccine. The site inspection
has been conducted by the panel comprising of Dr Noor Muhammad Shah and Prof Dr. Ijaz
Ahmad, the report was submitted on 22.05.2013. The panel has recommended their products and
the site at Fort Dodge Saude Animal Ltda, Brazil for cGMP compliance. The products are as
follows:
S.No. Registration Existing Brand name New requested Inspection
Number Brand Name Report
Remarks
1 009677 EDS Vaccine EDS Vac. Good
2 003787 Poulvac Marek Poulvac Ovoline Good
(CVI+HVT) (CVI+HVT)
3 010719 Egg Drop Syndrome- EDS New Bronz Good
Newcastle Disease Vac.
Infectious Bronchitis
Vaccine

The firm had also applied for inspection of their foreign site for the manufacture of diluent for
their already registered vaccine Poulvac Ovoline CVI+HVT Reg No. 003787 under the new
DRAP policy to register the diluent as a separate entity; the same panel also visited the diluent
manufacturing site at M/s Baxter Hospitalar Ltda, Brazil and recommended the product and the
plant for cGMP compliance.
S.No. Registration Brand Name Inspection Report
Number Remarks
1 New to be supplied Pro-Cell sterile diluent for Good
with vaccine Marek Vaccine reg no.
003787

Decision: The Board approved change of manufacturing site and brand name for above
products. The Board also approved registration of diluent for Poulvac Ovoline vaccine.

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b) M/s Martin Dow had applied for the registration of six biological products which were
approved in the 237th DRB meeting and for which panel inspection was conduct by a
panel consisting of Dr Uzar ul Ghani, Dr Najmus Saqib of the firm M/s Nanogen
Biopharmaceuticals, Tang NhonPhua ward, Vietnam. The panel has submitted the report
on 09.04.2013 and have recommended following products for registration:
S. No. Product Brand Generic name Inspection Report
Name Remarks
1. PEGNANO, PFS Peg Interferon alfa-2a 180 Good
mcg
2. FERONSURE, Interferon alfa-2a 3MIU Good
PFS
3. FERONSURE, Interferon alfa-2a 3 MIU Good
VIAL
4. NANOKINE, Erythropoietin alfa, 4000 Good
PFS IU
5. FICOCYTE, PFS Filgrastim, 30 mcg Good
6. PEGCYTE, PFS Peg Filgrastim, 6 mg Good

Decision: Registration Board deferred above cases for confirmation of evaluation by

ECBD.

c) M/s Aster had applied for the registration of their five biological products which were
approved in 237th DRB. Panel inspections have been conducted for the inspection of their
three biological products to be imported from M/s LG Korea. The inspection has been
conducted by Mr. Ghulam Rasool Dutani and Mr. Arif Choudary. They have
recommended these products and manufacturer for cGMP compliance. The same panel
has also recommended two biological products to be imported by the same company
from M/s Beijing Shuanglu Pharmaceutical Co. Ltd., China.
S. No. Product Brand Generic name Inspection Report
Name Remarks
1. Consensus- Each Vial containing Good
Asteron alpha 9 Recombinant Consensus M/s Beijing Shuanglu
mcg injection Interferon alpha 9 mcg, Pharmaceutical Co.
Ltd., China
2. Consensus- Each Vial containing Good
Asteron alpha 15 Recombinant Consensus M/s Beijing Shuanglu
mcg Injection Interferon alpha 15 mcg Pharmaceutical Co.

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 Ltd., China
3. Epotiv Recombinant human Good
2,000IU/0.5ml Pre- erythropoietin 2,000 M/s LG Lifge
filled syringe. IU/0.5ml Sciences. Ltd., Korea
4. Epotiv Recombinant human Good
4,000IU/0.4ml Pre- erythropoietin, 4,000 M/s LG Lifge
filled syringe IU/0.4ml Sciences. Ltd., Korea
5. Epotiv 10,000I Recombinant human Good
U/ml Injection erythropoietin 10,000 M/s LG Lifge
10000 IU/ml Pre- IU/ml Sciences. Ltd., Korea
filled syringe

Decision: Registration Board deferred above cases for confirmation of evaluation by

ECBD.

Case No.27: FDA/EMA/TGA/WHO approved new cases of important Biologicals for

registration as per import policy.

S.No. Product Name Drug Category/ Applicati Registration Status Revised

Major Indication on/Dossie Fee/
r Filing EMA Fee
Date US-FDA Differential
Australia (TGA) Paid
Japan

1. PROLIA Injection NCE/Post 14.11.201 EMA - Yes

(Denosumab 60mg) Menopausal 1 Approved
Importer M/s Osteoporosis US FDA -
GlaxoSmithKline, and bone loss in Approved
Karachi patients Complete dossier
undergoing present
From Manufacturer: hormone ablation EMA CPP verified
M/s Amgen for prostate or by Embassy of
Manufacturing breast cancer. Pakistan present
Limited, Juncos, Each prefilled
Puerto Rico, USA syringe contains
60mg of
denosumab in 1ml
solution
(60mg/1ml)
2. XGEVA Injection NCE/Cancer 15.05.201 EMA - Yes
(Denosumab 120mg) Therapy – 2 Approved
prevention of US FDA -
Importer M/s skeletal related Approved

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 GlaxoSmithKline, events with bone Complete dossier
Karachi metastates from present
solid tumors. FDA CPP verified
From Manufacturer: by Embassy of
M/s Amgen Each vial contains Pakistan present
Manufacturing 120mg of
Limited, Juncos, denosumab in 1.7
Puerto Rico, USA ml solution
(70mg/1ml)

Shelf life 36
months
3. BENLYSTA Injection autoantibody 16.05.201 EMA - Yes
(Belimumab 120mg) positive Systemic 2 Approved
lupus US FDA -
Importer M/s erythematosus Approved
GlaxoSmithKline, (SLE) Complete dossier
Karachi. present
Manufacturer: M/s Each vial contains CPP verified by
Hospira Inc, Kansas, 120 mg Embassy of Pakistan
USA. Supplying site: belimumab present
GlaxoSmithKline (80mg/ml after
Manufacturing S.p.a., reconstitution)
Pharma, Itlay.
Shelf life 36
months
4. BENLYSTA Injection autoantibody 16.05.201 EMA - Yes
(Belimumab 400mg) positive Systemic 2 Approved
lupus US FDA -
Importer M/s erythematosus Approved
GlaxoSmithKline, (SLE) Complete dossier
Karachi. present
Manufacturer: M/s Each vial contains CPP verified by
Hospira Inc, Kansas, 400 mg Embassy of Pakistan
USA. Supplying site: belimumab present
GlaxoSmithKline (80mg/ml after
Manufacturing S.p.a., reconstitution)
Pharma, Itlay. Shelf life 36
months
5. Qlaira, (eastradiol Hormone 24.08.201 TGA approved Yes
valerate) Hormone replacement 1 CPP verified by
combination therapy Embassy of Pakistan
present
Importer M/s Bayer Film coated tablet Complete dossier
Pakistan (Pvt) Ltd., contains: 3.0 mg present
Karachi from estradiol valerate

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 M/s Bayer Weimer as active
GmbH und Co. KG ingredients
Doebereinerstrasse 20
99427 Weimer,
Germany.
6. Eylea (Aflibercept) Ophthalmogicals/ 29.03.201 EMA/FDA approved Yes
40mcg/ml neurovascular 3 EMA CPP verified
degeneration by Embassy of
Importer M/s Bayer Pakistan present
Pakistan (Pvt) Ltd., Each vial contains Complete dossier
Karachi from Aflibercept 40 present
M/s Bayer Pharma AG mg/ml
Mullerstrabe 178
13353 Berlin Shelf life 2 years
Germany.
7. Yellow fever vaccine Yellow fever 11.09.201 WHO prequalified Yes
(live Freezedried) 2 vaccine 3 vaccine,
doses ampoules/1.0 ml
Importer M/s Hospital Each single 0.5ml The other yellow
Services & Sales, dose of vaccine fever vaccine
Karachi from contains: available from M/s
Federal State Unitary Yellow fever virus Sanofi Aventis,
Enterprise on no less than 1,000 France has
Manufacture of LD50 or 1,600 PFU developed some
Bacterial and Viral technical problems
Preparations of Supplied with as notifed by the
Chumakov Institute of diluent water for company on
Poliomyelitis & Viral injection 1.25 ml 11.09.2013 so
Encephalitis, Russian in ampoules supply of another
Academy of Medical vaccine is necessary
Sciences, Russia. to cover any
shortage, hence this
application is
presented
CPP, FSC, GMP
certificate, and other
relevant documents
verified by the
Pakistan Embassy
present
8. Yellow fever vaccine Yellow fever 11.09.201 -do- Yes
(live Freezedried) 5 vaccine 3
doses ampoules/2.5 ml
Importer M/s Hospital Each single 0.5ml
Services & Sales, dose of vaccine
Karachi from contains:

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 Federal State Unitary Yellow fever virus
Enterprise on no less than 1,000
Manufacture of LD50 or 1,600 PFU
Bacterial and Viral
Preparations of Supplied with
Chumakov Institute of diluent water for
Poliomyelitis & Viral injection 3.0 ml in
Encephalitis, Russian ampoules
Academy of Medical
Sciences, Russia.

Decision: Registration Board referred above case for consideration of ECBD, as

these cases have not been yet evaluated by the aforementioned committee.

Case No. 28: Change of source of an approved vaccine for local manufacture:

The case relates to “Bulk import local repacking” of the then WHO prequalified vaccine
i.e., Pentavalent vaccine that was approved in 213 DRB meeting with the following
composition and source:
From: Amsovax-5: Diptheria, Tetanus, whole cell Pertussis, Hepatitis-B and
Haemophilus influenza type B conjugate vaccine as per WHO formula, from M/s
Shanta Biotech India, India.

 At the time of application this source was WHO prequalified but latter on it
was derecognised by WHO, hence the local company applied for change of
source to a new WHO prequalified source;

To: Amsovax-5: New WHO prequalified product from M/s Biological E, Ltd., India
with the same composition of vaccine. The application was submitted on 16.09.2011
and the dossier of the new product was submitted on 28.10.2011. The vaccine is
Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus
Type B Conjugate Vaccine (Adsorbed)-(Hib vaccine lyophilised in separate vial
which is to be reconstituted with DTwP-rHepB vaccine filled in a separate vial).
Shelf life is 24 months. The packing applied for is 10 doses per vial. As per Schedule
I of DRAP Act, 2012 the naked vials without labels will be imported in bulk
quantities that will be locally labelled and Vaccine Vials Monitor (VVM) will be
applied before packing in cartons).

The firm was communicated the approval on 11.03.2013 and was asked to submit the
WHO approval and technical information on the CTD format; the firm submitted the
required information on 01.04.2013. The WHO approval status has been verified
from the WHO Web site as well.

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 The local facility is a licensed to manufacture vaccine by way of formulation since
1995 for HepB, TT, and antivenom serum; recommended for approval subject to
local panel inspection for facility suitability for handling such product.

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

Case No. 29: Registration of WHO prequalified liquid Pentavalent vaccine to be

imported in finished form for EPI in single vial.

M/s Amson Vaccine & Pharma (Pvt) Ltd., Islamabad submitted a case for import of a
Pentavalent vaccine in finished form for EPI from M/s Biological E. Ltd., India. Rs
100,000 fee has been paid. The vaccine is WHO prequalified and has following
composition:

Source: Composition Presentation

M/s Biological E Ltd., Diphtheria Toxoid 25Lf(≥30IU) 10 dose vials
Shameerpet Mandal, Tetanus Toxoid 5.5Lf(≥60IU)
Andhra Pradesh, India B.pertissis (Whole cell)
16IOU(≥4IU)
r-HBsAg 12.5 mcg
Purified capsular polysaccharide 11
mcg
Tetanus Toxoid (Carrier protein)
30.36.7mcg
Al+++ (as AlPO4) ≤1.25 mg
Thiomersal BP 0.01%w/v

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

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Case No. 30: Registration of safe drugs.
Registration Board discussed letter written by Dr.Obaid Ali, Deputy Drug
Controller dated 22.08.2013 on matter of registration of drugs. The Board discuused points
mentioned in letter as follows:
a. Registration of Drugs without Assessment, Review and evaluation of Application
Dossier.
The Board showed their satisfaction on present system of scrutinization / evaluation of
registration applications. The Board was informed that DRAP has agreed in principal to creat a
cell for evaluation of registration applications. The cell will be operative soon and will be
entrusted with the duty of scrutinization / evaluation of registration applications as required
under Drug Act, 1976.
b. Registration of Drugs without Assessment of site master file etc and GMP inspection.
As per procedure in vogue, licensing section is responsible for the grant of licenses / sections
to pharmaceutical units after completion of all requirements as required under Drugs (Licensing,
Registering & Advertising) Rules, 1976. Registration Board considers registration application on
the basis of approvals granted by licensing section. Similarly Quality Assurance section conducts
inspections of licensed units for compliance towards GMP. Registration Board considers these
inspection reports while considering registration applications. Moreover, the Board also
constitutes its own panel for product specific inspections, where it considers necessary. Members
of the Board were satisfied with the procedure adopted for inspection of pharmaceutical units.
However, for better compliance of GMP, the Board advised QA section to strictly monitor the
GMP of the licensed units for manufacturing of quality products for ailing masses.
c. Registration of Drugs without summary of approvals and transparency.
As mentioned in point a, the evaluation cell will evaluate the registration applications and
forward its recommendation including summary of approval for consideration of the Board.
Registration applictions are included in agenda of the meeting on FIFO basis.
d. Registration of Drugs without Post Marketting Requirements & Commitments.
After promulgation of DRAP Act, 2012; Pharmacovigilance section has been established
under Pharmacy Services Division. This section will perform all the activities of
Pharmacovigilance including post marketing survelliance etc of the marketed products. The
pharmaceutical companies will coordinate with this section for matters related to

190
pharmacovigilance. Members showed their desire that Registration Board be informed about the
pharmacovigilance activities per formed by the Pharmacy Services Division.
e. Registration of drugs/ Blanket approval on its Label Claim and Promotion.
Regsitartion Board grant registration of drug based on label claim approved by the regulatory
body of country of origin / USFDA / EMA / TGA / Japan / developed countries. However,
evaluation cell for the scrutinization / evaluation of registration application will also review all
label claims of the applicant.
f. Ignorance of International Norms and implementation of Harmonized Documents.
Presently registration applications are submitted on prescribed Forms (5, 5A, 5D, 5E) as
required under Drugs (Licensing, Registering & Advertising) Rules, 1976. The matter of
submission of the application on CTD format is already under discuusion in DRAP and will be
implemented after ammendement in aforementioned rules.
g. Barricade of working of DDC (Biological Drugs) and authorization of illegitimate
working.
It is an administrative matter and not related to Registration Board.

X X
Dr. Obaid Ullah Mr. Ghulam Rasool Dutani
Secretary, Drug Registration Board Chairman, Drug Registration Board

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